ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
Report
- Report Number
- 1221359-2023-00522
- Event Type
- Malfunction
- Date Received
- March 20, 2023
- Date of Event
- March 13, 2023
- Report Date
- August 1, 2023
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- MZF
- UDI-DI
- 00811877011101
- PMA / PMN Number
- BP120037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.B7 H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED; SINGLE-USE DEVICE.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.B7, H6 - COMPONENT CODE, HEALTH EFFECT - IMPACT CODE H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. THE CUSTOMER STATED THAT PATIENT TESTED WITH SIEMENS ATELLICA HIV PERFORMED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS PENDING AS OF (B)(6) 2023. ADDITIONAL HIV TEST WITH SIEMENS ATELLICA REACTIVE COMBO HIV WAS CONDUCTED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. THE CUSTOMER STATED THAT PATIENT TESTED WITH SIEMENS ATELLICA HIV PERFORMED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS PENDING AS OF (B)(6) 2023. ADDITIONAL HIV TEST WITH SIEMENS ATELLICA REACTIVE COMBO HIV WAS CONDUCTED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR MULTIPLE TESTS PERFORMED FROM (B)(6) 2023 TO (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. ADDITIONAL TESTING WITH SIEMENS ATELLICA (REACTIVE COMBO) HIV WAS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. THE CUSTOMER STATED THAT PATIENT TESTED WITH SIEMENS ATELLICA HIV PERFORMED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON 13MAR2023 TO CONFIRM HIV RESULTS. RESULTS PENDING AS OF (B)(6) 2023. ADDITIONAL HIV TEST WITH SIEMENS ATELLICA REACTIVE COMBO HIV WAS CONDUCTED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR MULTIPLE TESTS PERFORMED FROM (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED ON 11MAR2023 AND (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. ADDITIONAL TESTING WITH SIEMENS ATELLICA (REACTIVE COMBO) HIV WAS PERFORMED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1766917 | ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T | TEST, HIV DETECTION | MZF | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 213565 | 00811877011101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |