SARS COV-2 COVID-19 PCR /ABBOTT NOW ID
Report
- Report Number
- MW5097428
- Event Type
- Other
- Date Received
- October 23, 2020
- Manufacturer
- ABBOTT MOLECULAR, INC
- Product Code
- QJR
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
CONSUMER REPORTS CONCERNS WITH COVID-19 TESTING AND RESULTS OF FAMILY MEMBERS. PER ATTACHMENTS, SELF AND SPOUSE TEST WAS IDENTIFIED AS SARS COV-2 COVID-19 THOUGH PER COMPLAINANT (B)(6) DOES NOT DO PCR TESTING. RESULTS IDENTIFY TEST NAME AS COVID-19 RAPID DIAGNOSTIC TEST COVID-19."THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS", PER CONSUMER. REPORTED TO (B)(6) AND LOCAL HEALTH DEPARTMENT. "HI (B)(6). THANK YOU FOR ALLOWING ME TO FORWARD MY INFORMATION. I DEFINITELY DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. I HAVE ATTACHED (B)(6) TEST RESULT FROM (B)(6) TAKEN ON (B)(6). SOME ITEMS TO NOTE: THE (B)(6) SAYS SARS COV-2 COVID-19 PCR UNDER TEST NAME. (B)(6) DOES NOT DO PCR TESTING. NOTICE UNDER MY RESULTS AND MY HUSBAND, (B)(6) RESULTS THE TEST NAME SAYS COVID-19 RAPID DIAGNOSTIC TEST COVID-19. THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS. ANOTHER ITEM TO NOTE: COLLECTED TIMES ARE DATED AFTER REPORTED TIMES. THE TIMES ARE ALSO INCONSISTENT WITH OUR APPOINTMENTS. (B)(6) APPOINTMENT FOR EXAMPLE WAS ON (B)(6) AT 10:15, BUT ACCORDING TO HER REPORT IT WAS COLLECTED AT 8:35 AND REPORTED AT 8:07. (B)(6) HAD A FOLLOW UP PCR TEST AT (B)(6) BECAUSE SHE HAD NO SYMPTOMS AT THE TIME OF TESTING AND SHE DID NOT DEVELOP ANY SYMPTOMS AFTER TESTING AND STILL AS OF TO DATE DOES NOT HAVE ANY SYMPTOMS. HER PCR TEST FROM (B)(6) CAME BACK NEGATIVE. I HAD TWO TESTS MYSELF ONE AT (B)(6) WHICH WAS NEGATIVE AND ONE AT (B)(6) WHICH WAS NEGATIVE. AS YOU CAN SEE FROM THE (B)(6) RESULTS THE LAB REPORTING IS VASTLY DIFFERENT. IN ADDITION, MY APPT TIME IS NOT CONSISTENT WITH REPORTING TIMES ON MY LAB REPORT OR MY HUSBANDS. WE DID GO TOGETHER ON (B)(6) BUT THE LAB COLLECTED SHOWS 12:28 AND REPORTED AT 11:53. WE DID NOT ARRIVE TO OUR APPT UNTIL 2PM. I WORK UNTIL 12 EVERY DAY AND I WAS LOGGED IN TO MY COMPANY'S VPN UNTIL 12. IF NEEDED I CAN PROVIDE PROOF OF THIS. LASTLY I CALLED (B)(6). I WAS TOLD (B)(6) OPERATES THE LAB AND WHEN I CALLED (B)(6) I WAS TOLD (B)(6) OPERATES THE LAB. (B)(6) ON ONE CALL GAVE ME A NAME OF A LAB THEY CALLED (B)(6). THIS IS NOT A LAB. THEY GAVE ME A FAKE NAME. I NOTICED A DR¿S NAME LISTED ON THE LAB REPORT. I (B)(6) THE DR. NAMED (B)(6). I CALLED HER OFFICE IN (B)(6). I WAS TOLD SHE NO LONGER WORKS THERE. THEY SAID SHE LIVES IN (B)(6). THEY DID GIVE ME AN NUMBER AND IT WAS THE SAME NUMBER AS (B)(6). I HAVE SPOKEN TO SEVERAL NURSES AT THE (B)(6) AND THEY HAVE EACH BEEN EQUALLY AMAZING. THEIR HANDS ARE TIED WITH THIS SITUATION BECAUSE ONCE YOU TEST POSITIVE, EVEN IF YOU HAVE SUBSEQUENT TESTS YOU ARE CONSIDERED POSITIVE AND MUST QUARANTINE 10 DAYS FROM THE TEST DATE EVEN IF YOU FEEL IT WAS A FALSE POSITIVE OR YOU CAN PROVE (IN OUR CASE OF A MORE RELIABLE PCR TEST). THE REST OF US ARE RECOMMENDED TO QUARANTINE 14 DAYS FROM THE DATE OF (B)(6) TEST. EVERYONE HAS BEEN TESTED AND WE ARE ALL NEGATIVE. WE LIVE IN THE SAME HOUSE. ALSO, ANYONE THAT CAME IN CONTACT WITH (B)(6) WAS ALSO TESTED AND TESTED NEGATIVE. I GIVE FULL PERMISSION TO RELEASE ANY AND ALL INFORMATION RELATING TO OUR TESTS OR ANYTHING ELSE TO YOU OR YOUR TEAM AS FAR AS THIS MATTER IS CONCERNED. I HAVE CONTACTED (B)(6) AND MADE A COMPLAINT. THE REQUISITION NUMBER IS (B)(4) FOR FURTHER INVESTIGATION HERE ARE ALL OF OUR NAMES AND DATE OF BIRTHS: (B)(6) MY DAUGHTER, (B)(6) WAS SUPPOSE TO MOVE INTO COLLEGE ON (B)(6). SHE WILL NOW NOT BE PERMITTED ON CAMPUS UNTIL (B)(6). MY HUSBAND IS IN SALES AND HE HAS NOT BEEN ABLE TO COMPLETE SALES CALLS BECAUSE OF THIS SITUATION. SINCERELY, (B)(6).
CONSUMER REPORTS CONCERNS WITH COVID-19 TESTING AND RESULTS OF FAMILY MEMBERS. PER ATTACHMENTS, SELF AND SPOUSE TEST WAS IDENTIFIED AS SARS COV-2 COVID-19 THOUGH PER COMPLAINANT (B)(6) DOES NOT DO PCR TESTING. RESULTS IDENTIFY TEST NAME AS COVID-19 RAPID DIAGNOSTIC TEST COVID-19."THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS", PER CONSUMER. REPORTED TO (B)(6) AND LOCAL HEALTH DEPARTMENT. "HI (B)(6). THANK YOU FOR ALLOWING ME TO FORWARD MY INFORMATION. I DEFINITELY DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. I HAVE ATTACHED (B)(6) TEST RESULT FROM (B)(6) TAKEN ON (B)(6). SOME ITEMS TO NOTE: THE (B)(6) SAYS SARS COV-2 COVID-19 PCR UNDER TEST NAME. (B)(6) DOES NOT DO PCR TESTING. NOTICE UNDER MY RESULTS AND MY HUSBAND, (B)(6) RESULTS THE TEST NAME SAYS COVID-19 RAPID DIAGNOSTIC TEST COVID-19. THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS. ANOTHER ITEM TO NOTE: COLLECTED TIMES ARE DATED AFTER REPORTED TIMES. THE TIMES ARE ALSO INCONSISTENT WITH OUR APPOINTMENTS. (B)(6) APPOINTMENT FOR EXAMPLE WAS ON (B)(6) AT 10:15, BUT ACCORDING TO HER REPORT IT WAS COLLECTED AT 8:35 AND REPORTED AT 8:07. (B)(6) HAD A FOLLOW UP PCR TEST AT (B)(6) BECAUSE SHE HAD NO SYMPTOMS AT THE TIME OF TESTING AND SHE DID NOT DEVELOP ANY SYMPTOMS AFTER TESTING AND STILL AS OF TO DATE DOES NOT HAVE ANY SYMPTOMS. HER PCR TEST FROM (B)(6) CAME BACK NEGATIVE. I HAD TWO TESTS MYSELF ONE AT (B)(6) WHICH WAS NEGATIVE AND ONE AT (B)(6) WHICH WAS NEGATIVE. AS YOU CAN SEE FROM THE (B)(6) RESULTS THE LAB REPORTING IS VASTLY DIFFERENT. IN ADDITION, MY APPT TIME IS NOT CONSISTENT WITH REPORTING TIMES ON MY LAB REPORT OR MY HUSBANDS. WE DID GO TOGETHER ON (B)(6) BUT THE LAB COLLECTED SHOWS 12:28 AND REPORTED AT 11:53. WE DID NOT ARRIVE TO OUR APPT UNTIL 2PM. I WORK UNTIL 12 EVERY DAY AND I WAS LOGGED IN TO MY COMPANY'S VPN UNTIL 12. IF NEEDED I CAN PROVIDE PROOF OF THIS. LASTLY I CALLED (B)(6). I WAS TOLD (B)(6) OPERATES THE LAB AND WHEN I CALLED (B)(6) I WAS TOLD (B)(6) OPERATES THE LAB. (B)(6) ON ONE CALL GAVE ME A NAME OF A LAB THEY CALLED (B)(6). THIS IS NOT A LAB. THEY GAVE ME A FAKE NAME. I NOTICED A DR¿S NAME LISTED ON THE LAB REPORT. I (B)(6) THE DR. NAMED (B)(6). I CALLED HER OFFICE IN (B)(6). I WAS TOLD SHE NO LONGER WORKS THERE. THEY SAID SHE LIVES IN (B)(6). THEY DID GIVE ME AN NUMBER AND IT WAS THE SAME NUMBER AS (B)(6). I HAVE SPOKEN TO SEVERAL NURSES AT THE (B)(6) AND THEY HAVE EACH BEEN EQUALLY AMAZING. THEIR HANDS ARE TIED WITH THIS SITUATION BECAUSE ONCE YOU TEST POSITIVE, EVEN IF YOU HAVE SUBSEQUENT TESTS YOU ARE CONSIDERED POSITIVE AND MUST QUARANTINE 10 DAYS FROM THE TEST DATE EVEN IF YOU FEEL IT WAS A FALSE POSITIVE OR YOU CAN PROVE (IN OUR CASE OF A MORE RELIABLE PCR TEST). THE REST OF US ARE RECOMMENDED TO QUARANTINE 14 DAYS FROM THE DATE OF (B)(6) TEST. EVERYONE HAS BEEN TESTED AND WE ARE ALL NEGATIVE. WE LIVE IN THE SAME HOUSE. ALSO, ANYONE THAT CAME IN CONTACT WITH (B)(6) WAS ALSO TESTED AND TESTED NEGATIVE. I GIVE FULL PERMISSION TO RELEASE ANY AND ALL INFORMATION RELATING TO OUR TESTS OR ANYTHING ELSE TO YOU OR YOUR TEAM AS FAR AS THIS MATTER IS CONCERNED. I HAVE CONTACTED (B)(6) AND MADE A COMPLAINT. THE REQUISITION NUMBER IS (B)(4) FOR FURTHER INVESTIGATION HERE ARE ALL OF OUR NAMES AND DATE OF BIRTHS: (B)(6) MY DAUGHTER, (B)(6) WAS SUPPOSE TO MOVE INTO COLLEGE ON (B)(6). SHE WILL NOW NOT BE PERMITTED ON CAMPUS UNTIL (B)(6). MY HUSBAND IS IN SALES AND HE HAS NOT BEEN ABLE TO COMPLETE SALES CALLS BECAUSE OF THIS SITUATION. SINCERELY, (B)(6).
CONSUMER REPORTS CONCERNS WITH COVID-19 TESTING AND RESULTS OF FAMILY MEMBERS. PER ATTACHMENTS, SELF AND SPOUSE TEST WAS IDENTIFIED AS SARS COV-2 COVID-19 THOUGH PER COMPLAINANT (B)(6) DOES NOT DO PCR TESTING. RESULTS IDENTIFY TEST NAME AS COVID-19 RAPID DIAGNOSTIC TEST COVID-19."THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS", PER CONSUMER. REPORTED TO (B)(6) AND LOCAL HEALTH DEPARTMENT. "HI (B)(6). THANK YOU FOR ALLOWING ME TO FORWARD MY INFORMATION. I DEFINITELY DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. I HAVE ATTACHED (B)(6) TEST RESULT FROM (B)(6) TAKEN ON (B)(6). SOME ITEMS TO NOTE: THE (B)(6) SAYS SARS COV-2 COVID-19 PCR UNDER TEST NAME. (B)(6) DOES NOT DO PCR TESTING. NOTICE UNDER MY RESULTS AND MY HUSBAND, (B)(6) RESULTS THE TEST NAME SAYS COVID-19 RAPID DIAGNOSTIC TEST COVID-19. THE INFORMATION WE RECEIVED AT (B)(6) WAS WE WERE TAKING THE ABBOT NOW ID TEST. IF YOU (B)(6) THE TEST, IT IS A RAPID TEST. A PCR TEST TAKES 4 TO 6 HOURS TO PROCESS. THE ABBOT NOW ID IS PROCESSED IN 15 MINUTES OR LESS. (B)(6) DOES NOT DO PCR TESTS. YOU HAVE TO GET THESE TYPES OF TESTS AT PLACES LIKE (B)(6) AND THE RESULTS ARE USUALLY TURNED AROUND WITHIN 36 HOURS. ANOTHER ITEM TO NOTE: COLLECTED TIMES ARE DATED AFTER REPORTED TIMES. THE TIMES ARE ALSO INCONSISTENT WITH OUR APPOINTMENTS. (B)(6) APPOINTMENT FOR EXAMPLE WAS ON (B)(6) AT 10:15, BUT ACCORDING TO HER REPORT IT WAS COLLECTED AT 8:35 AND REPORTED AT 8:07. (B)(6) HAD A FOLLOW UP PCR TEST AT (B)(6) BECAUSE SHE HAD NO SYMPTOMS AT THE TIME OF TESTING AND SHE DID NOT DEVELOP ANY SYMPTOMS AFTER TESTING AND STILL AS OF TO DATE DOES NOT HAVE ANY SYMPTOMS. HER PCR TEST FROM (B)(6) CAME BACK NEGATIVE. I HAD TWO TESTS MYSELF ONE AT (B)(6) WHICH WAS NEGATIVE AND ONE AT (B)(6) WHICH WAS NEGATIVE. AS YOU CAN SEE FROM THE (B)(6) RESULTS THE LAB REPORTING IS VASTLY DIFFERENT. IN ADDITION, MY APPT TIME IS NOT CONSISTENT WITH REPORTING TIMES ON MY LAB REPORT OR MY HUSBANDS. WE DID GO TOGETHER ON (B)(6) BUT THE LAB COLLECTED SHOWS 12:28 AND REPORTED AT 11:53. WE DID NOT ARRIVE TO OUR APPT UNTIL 2PM. I WORK UNTIL 12 EVERY DAY AND I WAS LOGGED IN TO MY COMPANY'S VPN UNTIL 12. IF NEEDED I CAN PROVIDE PROOF OF THIS. LASTLY I CALLED (B)(6). I WAS TOLD (B)(6) OPERATES THE LAB AND WHEN I CALLED (B)(6) I WAS TOLD (B)(6) OPERATES THE LAB. (B)(6) ON ONE CALL GAVE ME A NAME OF A LAB THEY CALLED (B)(6). THIS IS NOT A LAB. THEY GAVE ME A FAKE NAME. I NOTICED A DR¿S NAME LISTED ON THE LAB REPORT. I (B)(6) THE DR. NAMED (B)(6). I CALLED HER OFFICE IN (B)(6). I WAS TOLD SHE NO LONGER WORKS THERE. THEY SAID SHE LIVES IN (B)(6). THEY DID GIVE ME AN NUMBER AND IT WAS THE SAME NUMBER AS (B)(6). I HAVE SPOKEN TO SEVERAL NURSES AT THE (B)(6) AND THEY HAVE EACH BEEN EQUALLY AMAZING. THEIR HANDS ARE TIED WITH THIS SITUATION BECAUSE ONCE YOU TEST POSITIVE, EVEN IF YOU HAVE SUBSEQUENT TESTS YOU ARE CONSIDERED POSITIVE AND MUST QUARANTINE 10 DAYS FROM THE TEST DATE EVEN IF YOU FEEL IT WAS A FALSE POSITIVE OR YOU CAN PROVE (IN OUR CASE OF A MORE RELIABLE PCR TEST). THE REST OF US ARE RECOMMENDED TO QUARANTINE 14 DAYS FROM THE DATE OF (B)(6) TEST. EVERYONE HAS BEEN TESTED AND WE ARE ALL NEGATIVE. WE LIVE IN THE SAME HOUSE. ALSO, ANYONE THAT CAME IN CONTACT WITH (B)(6) WAS ALSO TESTED AND TESTED NEGATIVE. I GIVE FULL PERMISSION TO RELEASE ANY AND ALL INFORMATION RELATING TO OUR TESTS OR ANYTHING ELSE TO YOU OR YOUR TEAM AS FAR AS THIS MATTER IS CONCERNED. I HAVE CONTACTED (B)(6) AND MADE A COMPLAINT. THE REQUISITION NUMBER IS (B)(4) FOR FURTHER INVESTIGATION HERE ARE ALL OF OUR NAMES AND DATE OF BIRTHS: (B)(6) MY DAUGHTER, (B)(6) WAS SUPPOSE TO MOVE INTO COLLEGE ON (B)(6). SHE WILL NOW NOT BE PERMITTED ON CAMPUS UNTIL (B)(6). MY HUSBAND IS IN SALES AND HE HAS NOT BEEN ABLE TO COMPLETE SALES CALLS BECAUSE OF THIS SITUATION. SINCERELY, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195957 | SARS COV-2 COVID-19 PCR /ABBOTT NOW ID | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT MOLECULAR, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | |||
| 2 | 45 YR | |||
| 3 | 51 YR |