XPERT MRSA/SA BC
Report
- Report Number
- 3004530258-2024-00007
- Event Type
- Death
- Date Received
- May 10, 2024
- Date of Event
- April 12, 2024
- Report Date
- May 28, 2024
- Manufacturer
- CEPHEID
- Product Code
- NQX
- UDI-DI
- 07332940000141
- PMA / PMN Number
- K130894
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 501
Narratives
CASE BACKGROUND: MULTIPLE ATTEMPTS WERE MADE BY CEPHEID TO OBTAIN NECESSARY INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. ON 4/18, PATIENT SAFETY BOARD (PSB) EMAILED AND THEN SPOKE TO THE CUSTOMER, WHO WAS UNABLE TO PROVIDE THE INFORMATION REQUESTED. ON 4/22, PSB CALLED THE CUSTOMER AND LEFT A VOICEMAIL. ON 4/23, PSB MADE ANOTHER ATTEMPT TO CALL THE CUSTOMER AND A VOICEMAIL WAS LEFT. ON 4/24, PSB EMAILED THE CUSTOMER AS WELL AS CALLED AND LEFT A VOICEMAIL. AN EMAIL WAS RECEIVED ON 5/6 FROM THE CUSTOMER APOLOGIZING FOR THE DELAY AND PROVIDING PARTIAL ANSWERS TO THE QUESTIONS POSED BY CEPHEID. ON 5/16, PSB AGAIN REACHED OUT TO THE CUSTOMER TO GET ADDITIONAL DETAILS AS BELOW: THE PATIENT'S PAST MEDICAL HISTORY, PAST SURGICAL HISTORY, ALLERGIES TO MEDICATIONS, AND HOME MEDICATIONS PATIENT WAS A 71 YO MALE WITH PAST MEDICAL HISTORY OF HYPERTENSION, DIABETES, CONGESTIVE HEART FAILURE, AND CHRONIC LOWER EXTREMITY WOUNDS. HE HAS NO DOCUMENTED PAST SURGICAL HISTORY. NO LISTED ALLERGIES. HE WAS ON OUTPATIENT MEDICATIONS INCLUDING ALBUTEROL, ASPIRIN, A STATIN, DIGOXIN, FOLIC ACID, ETC. HE HAD A PICC LINE TO ADMINISTER MEDICATIONS. THE PICC LINE WAS REMOVED A WEEK PRIOR TO HOSPITALIZATION AND PLACED IN THE OTHER ARM. TREATMENTS THE PATIENT RECEIVED DURING THE HOSPITALIZATION (INCLUDE ALL ANTIBIOTICS AND ANTIVIRAL MEDICATIONS) PATIENT PRESENTED ON (B)(6) 2024. HE WAS STARTED ON VANCOMYCIN AND CEFEPIME ON (B)(6). LABORATORY TESTS OBTAINED (FOR EXAMPLE, INCLUDE COMPLETE WHITE BLOOD COUNT, COMPREHENSIVE METABOLIC PANEL, LACTATE). LAB TESTS INCLUDE BLOOD CULTURES COLLECTED (B)(6). ADDITIONAL (B)(6) LABS WERE NOTABLE FOR HYPONATREMIA, ABNORMAL CREATININE OF 2.3 (HIGH), ABNORMAL LACTATE OF 4 (HIGH), WHITE BLOOD CELL COUNT OF 12.9 (HIGH) AND PLATELET COUNT OF 99 (LOW). RELEVANT IMAGING (INCLUDING CHEST X-RAY, CT SCANS). X-RAY AND CT SCAN OF CHEST/ABDOMEN/PELVIS WERE NOTABLE FOR LUNG NODULAR GROUND-GLASS OPACITIES LEADING TO DIAGNOSIS OF PULMONARY EDEMA VERSUS PNEUMONIA. MICROBIOLOGY DATA (BLOOD, SPUTUM, URINE CULTURES, IF OBTAINED). URINE CULTURE COLLECTED (B)(6) GREW ANTIBIOTIC SUSCEPTIBLE KLEBSIELLA PNEUMONIAE. A SPUTUM SPECIMEN COLLECTED (B)(6) GREW NORMAL RESPIRATORY FLORA. BLOOD CULTURES COLLECTED ON (B)(6) FLAGGED POSITIVE ON (B)(6). THE INITIAL XPERT MRSA/SA BC RESULT WAS NEGATIVE. CULTURES WERE ALSO SET UP FROM THE SAME BOTTLE AND GREW MRSA. BECAUSE OF THE DISCREPANT XPERT AND CULTURE RESULTS, THE CUSTOMER REPEATED THE XPERT MRSA/SA BC TEST ON (B)(6), ON THE SAME BOTTLE THAT HAD BEEN STORED AT ROOM TEMPERATURE SINCE (B)(6). THE REPEAT XPERT TEST WAS POSITIVE FOR MRSA/SA (SPA CT VALUE 14.1; MECA CT VALUE 15.3; SCC CT VALUE 15.9). EVENTS LEADING TO CAUSE OF DEATH: PATIENT HAD CARDIAC ARREST X2 ON (B)(6); SEPTIC SHOCK; ACUTE KIDNEY INJURY. CAUSE OF DEATH: ACCORDING TO THE MEDICAL CHARTS THE CAUSE OF DEATH WAS ATTRIBUTED TO TWO CARDIAC ARRESTS AND SEPTIC SHOCK, TOGETHER WITH A FAMILY DECISION TO REDUCE MEDICAL CARE TO COMFORT LEVEL ONLY. PLEASE ALSO PROVIDE AN UPDATE OF ANY INVESTIGATION CEPHEID IS CONDUCTING FOR THIS EVENT IN ORDER TO DETERMINE THE CAUSE OF THE FALSE NEGATIVE RESULT. BASED ON ADDITIONAL INFORMATION RECEIVED ON 5/16, THE INITIAL FALSE NEGATIVE XPERT MRSA/SA BC RESULT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH, AS PATIENT WAS ON THE APPROPRIATE ANTIBIOTIC FOR MRSA SINCE ADMISSION (VANCOMYCIN). THE LIKELY ROOT CAUSE FOR THIS FALSE NEGATIVE RESULT IS INCONCLUSIVE. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION. THE XPERT TEST WAS PERFORMED BY THE CUSTOMER USING THE ANAEROBIC BLOOD CULTURE BOTTLE WHICH IS OFF-LABEL. THE PERFORMANCE OF XPERT MRSA/SA BC USING ANAEROBIC BLOOD CULTURE BOTTLES HAS NOT BEEN ESTABLISHED BY CEPHEID. PRE-ANALYTICAL ERROR (SAMPLE MIX UP) CAN ALSO CAUSE THIS TYPE OF DISCREPANCY, BUT IN THIS CASE THE CUSTOMER DID NOT ADMIT TO THIS. CLINICAL CODE E HAS ALSO BEEN UPDATED TO REFLECT THE ABOVE INFORMATION PROVIDED.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT WHERE THE INITIAL RESULTS WERE MRSA AND SA NEGATIVE, AND THE REPEAT RUN WAS MRSA AND SA POSITIVE. THE SITE COLLECTED A BLOOD SAMPLE FROM PATIENT ON (B)(6) 2024. THE SITE CONFIRMED THEY USED A BD BACTEC PLUS BOTTLE TO INCUBATE THE SAMPLE, AND THEY STATED THEY USED BOTH AN AEROBIC AND ANAEROBIC BOTTLE FOR PATIENT SAMPLE. THE BOTTLES WERE IN THE INCUBATOR FOR LESS THAN A DAY BEFORE THEY FLAGGED POSITIVE ACCORDING TO THE SITE. NO TIME WAS PROVIDED OR CONFIRMATION WHETHER BOTH OR JUST ONE BOTTLE FLAGGED POSITIVE, BUT SITE STATED IT FLAGGED POSITIVE ON (B)(6) 2024 AND WAS HELD AT ROOM TEMPERATURE ONCE TAKEN OUT OF THE INCUBATOR. SITE STATED A GRAM STAIN WAS PERFORMED AND IT WAS POSITIVE FOR GRAM COCCI CLUSTERS. ON (B)(6)2024 PATIENT 1 SAMPLE 1 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA NEGATIVE SA NEGATIVE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SITE STATED THEY FOLLOWED THE IFU. ON (B)(6)2024 PATIENT 1 SAMPLE 2 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA POSITIVE SA POSITIVE. IT WAS NOT CONFIRMED BY SITE THAT THESE RESULTS WERE REPORTED TO THE PHYSICIAN. CUSTOMER DID NOT CONFIRM WHETHER SAMPLE WAS LEFT AT ROOM TEMPERATURE BETWEEN TESTS OR PLACED IN THE REFRIGERATOR. THE SITE STATED TESTING FROM BLOOD AGAR AND CHOCOLATE AGAR PLATES YIELDED MRSA POSITIVE RESULTS. THE SITE STATED MALDI-TOF TESTING WAS DONE AND YIELDED POSITIVE RESULTS. SUSCEPTIBILITY TESTING WAS DONE ON THE BD PHOENIX PLATFORM AND THE RESULTS WERE MRSA POSITIVE. ON (B)(6)2024, SITE REPORTED PATIENT WAS DECEASED TO CEPHEID. THE SITE STATED THE CARTRIDGES ARE STORED AT ROOM TEMPERATURE. THE SAMPLE WAS NEVER FROZEN. ON (B)(6) 2024, CUSTOMER REPORTED THEY DID NOT KNOW WHEN THE PATIENT PASSED AND WHETHER IT WAS ATTRIBUTED TO RESULTS REPORTED OUT. THE SITE STATED THE CULTURES ON THE BLOOD AGAR AND CHOCOLATE AGAR PLATES WERE NOT MIXED, AND THE PLATES RESULTS WERE USED "TO FINAL CULTURE. INFECTIOUS DISEASE DOCTORS ARE CONCERNED ABOUT THE DISCREPANT RESULTS." THE CUSTOMER STATED THE MALDI-TOF RESULTS WERE SA AND NO COAGULASE TESTING WAS DONE, BUT THEY DID NOT SHARE WHETHER OR NOT THE MALDI RESULTS WERE REPORTED TO THE PHYSICIAN. CUSTOMER CONFIRMED THE BLOOD CULTURE SAMPLE USED FOR TESTING WAS STORED ON SHELF NEAR THE INSTRUMENT, AKA STORED AT ROOM TEMPERATURE FROM (B)(6)2024 TO (B)(6)2024, BUT STILL DIDN'T CONFIRM WHICH BOTTLE WAS USED FOR THE TESTING. THE CUSTOMER DID CONFIRM AFTER CHECKING WITH ID DOCTOR THAT THE PATIENT HAD A COMPLICATED MEDICAL HISTORY AND WAS ON THE APPROPRIATE ANTIBIOTIC FOR MRSA. SHE ALSO CONFIRMED THAT THEY TESTED THE ANAEROBIC BLOOD CULTURE BOTTLE IN BOTH THE FIRST AND SECOND TEST WHICH IS OFF LABEL. THEY VALIDATED THIS TYPE OF BOTTLE IN HOUSE. THE TEST RESULT DID NOT MAKE ANY DIFFERENCE IN HOW THE PATIENT WAS TREATED. QC RECORDS FOR THE CARTRIDGE LOT SHOWED NO PROBLEMS EXCEPT FOR ONE ERROR 1002 (TEMPERATURE) AND ONLY TWO COMPLAINTS TO TS WERE SUBMITTED FOR LOT 20903 BOTH FROM THIS CUSTOMER. IT IS THE SUSPICION THAT BARRING OPERATOR ERROR, EITHER MULTIPLE BLOOD CULTURE BOTTLES ARE BEING SAMPLED AND TESTED/CULTURED (MAYBE ANAEROBIC AND AEROBIC OF FROM MULTIPLE BODY SITES) THEREFORE YIELDING DISCORDANT RESULTS OR ANAEROBIC BLOOD CULTURE BOTTLE IS BEING TESTED AND THE ADDITIONAL INGREDIENTS CONTAINED IN THE ANAEROBIC BLOOD CULTURE BROTH ARE INTERFERING WITH THE REACTION. ATTEMPTS TO DIRECTLY ASSESS POTENTIAL HARM TO THE PATIENT WERE UNSUCCESSFUL. THE LIKELY ROOT CAUSE IN THIS CASE IS INCONCLUSIVE DUE TO LACK OF INFORMATION FROM THE CUSTOMER. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT MRSA/SA BC TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT WHERE THE INITIAL RESULTS WERE MRSA AND SA NEGATIVE, AND THE REPEAT RUN WAS MRSA AND SA POSITIVE. THE SITE COLLECTED A BLOOD SAMPLE FROM PATIENT ON (B)(6) 2024. THE SITE CONFIRMED THEY USED A BD BACTEC PLUS BOTTLE TO INCUBATE THE SAMPLE, AND THEY STATED THEY USED BOTH AN AEROBIC AND ANAEROBIC BOTTLE FOR PATIENT SAMPLE. THE BOTTLES WERE IN THE INCUBATOR FOR LESS THAN A DAY BEFORE THEY FLAGGED POSITIVE ACCORDING TO THE SITE. NO TIME WAS PROVIDED OR CONFIRMATION WHETHER BOTH OR JUST ONE BOTTLE FLAGGED POSITIVE, BUT SITE STATED IT FLAGGED POSITIVE ON (B)(6)2024 AND WAS HELD AT ROOM TEMPERATURE ONCE TAKEN OUT OF THE INCUBATOR. SITE STATED A GRAM STAIN WAS PERFORMED AND IT WAS POSITIVE FOR GRAM COCCI CLUSTERS. ON (B)(6)2024 PATIENT 1 SAMPLE 1 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA NEGATIVE SA NEGATIVE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SITE STATED THEY FOLLOWED THE IFU. ON (B)(6)2024 PATIENT 1 SAMPLE 2 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA POSITIVE SA POSITIVE. IT WAS NOT CONFIRMED BY SITE THAT THESE RESULTS WERE REPORTED TO THE PHYSICIAN. CUSTOMER DID NOT CONFIRM WHETHER SAMPLE WAS LEFT AT ROOM TEMPERATURE BETWEEN TESTS OR PLACED IN THE REFRIGERATOR. THE SITE STATED TESTING FROM BLOOD AGAR AND CHOCOLATE AGAR PLATES YIELDED MRSA POSITIVE RESULTS. THE SITE STATED MALDI-TOF TESTING WAS DONE AND YIELDED POSITIVE RESULTS. SUSCEPTIBILITY TESTING WAS DONE ON THE BD PHOENIX PLATFORM AND THE RESULTS WERE MRSA POSITIVE. ON (B)(6)2024, SITE REPORTED PATIENT WAS DECEASED TO CEPHEID. THE SITE STATED THE CARTRIDGES ARE STORED AT ROOM TEMPERATURE. THE SAMPLE WAS NEVER FROZEN. ON (B)(6)2024, CUSTOMER REPORTED THEY DID NOT KNOW WHEN THE PATIENT PASSED AND WHETHER IT WAS ATTRIBUTED TO RESULTS REPORTED OUT. THE SITE STATED THE CULTURES ON THE BLOOD AGAR AND CHOCOLATE AGAR PLATES WERE NOT MIXED, AND THE PLATES RESULTS WERE USED "TO FINAL CULTURE. INFECTIOUS DISEASE DOCTORS ARE CONCERNED ABOUT THE DISCREPANT RESULTS." THE CUSTOMER STATED THE MALDI-TOF RESULTS WERE SA AND NO COAGULASE TESTING WAS DONE, BUT THEY DID NOT SHARE WHETHER OR NOT THE MALDI RESULTS WERE REPORTED TO THE PHYSICIAN. CUSTOMER CONFIRMED THE BLOOD CULTURE SAMPLE USED FOR TESTING WAS STORED ON SHELF NEAR THE INSTRUMENT, AKA STORED AT ROOM TEMPERATURE FROM (B)(6) 2024 TO (B)(6)2024, BUT STILL DIDN'T CONFIRM WHICH BOTTLE WAS USED FOR THE TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 904135 | XPERT MRSA/SA BC | XPERT MRSA/SA BLOOD CULTURE | NQX | CEPHEID | 1001414410 | 07332940000141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Death |