| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ABBOTT REALTIME CMV AMPLIFICATION REAGENT | CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY | ABBOTT MOLECULAR, INC. | PAB | 09N21-090 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-02 | 0 |
Patient 1
COMPLAINT INVESTIGATION WILL BE PERFORMED. NOTE: LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT ABBOTT REALTIME CMV AMPLIFICATION REAGENT (5N23-90) IS SIMILAR TO THE ABBOTT REALTIME CMV AMPLIFICATION REAGENT (09N21-090) SOLD IN THE UNITED STATES. TICKET DOES NOT REFERENCE A US LIST 09N21-090 LOT NUMBER.
Patient 1
THE ABBOTT REALTIME CMV ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR THE QUANTITATION OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN PLASMA OR WHOLE BLOOD. THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS AS AN INDICATOR OF INITIATION OF THERAPY AND FOR USE AS AN AID IN MONITORING VIRAL RESPONSE TO ANTIVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA OR WHOLE BLOOD DNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A SCREENING TEST FOR CMV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF CMV INFECTION. THE CUSTOMER ENCOUNTERED A DISCREPANT RESULT WHEN RUNNING THE REALTIME CMV WHOLE BLOOD RUN. THE QUESTIONED RESULT WAS 2045 COPIES/ML. THE CLINICAL PHYSICIAN ASKED FOR A RESISTANCE GENOTYPE TO BE RUN BECAUSE THIS RESULT WAS X10 MORE THAN THE PREVIOUS RESULT. THE LAB SENT THIS SAMPLE, ALIQUOTED FROM THE SAME PRIMARY TUBE TO ANOTHER LAB FOR GENOTYPING. THE OUTSIDE LAB RAN THE VIRAL LOAD BEFORE PERFORMING THE RESISTANCE GENOTYPE AND FOUND 125 UI/ML (QIAGEN METHOD). AS A RESULT, THE OUTSIDE LAB DID NOT PERFORM THE GENOTYPING, SO THE REMAINING SAMPLE WAS SENT BACK TO THE CUSTOMER'S LAB. ON (B)(6) 2018, THE LAB RETESTED THE INITIAL STORED SAMPLE AND THE SAMPLE THAT CAME BACK FROM THE OTHER LAB (DILUTED ?, BECAUSE NOT ENOUGH VOLUME). THE RESULT FROM THE INITIAL STORED SAMPLE WAS 201 COPIES /ML (313 UI/ML) AND ALTHOUGH DILUTION IS NOT SUPPORTED BY THE REALTIME CMV ASSAY, THE RESULT OF THE DILUTED SAMPLE WAS 40 COPIES/ML, SO PURE 80 COPIES/ML (125 UI/ML). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED IN ASSOCIATION WITH THESE QUESTIONED RESULTS. ALTHOUGH, IT IS UNKNOWN AT THIS TIME IF A MALFUNCTION HAS OCCURRED. IF THIS OBSERVATION WAS CAUSED BY AN ABBOTT PRODUCT MALFUNCTION AND THAT MALFUNCTION WERE TO RECUR, A FALSE NEGATIVE RESULT IN THE REALTIME CMV ASSAY HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. HISTORY OF THE PATIENT: WOMAN, (B)(6). THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING REALTIME CMV ASSAY, LIST NUMBER 5N23-90 WHICH IS THE SAME/ SIMILAR TO US FDA APPROVED REALTIME CMV LIST NUMBER 09N21-090.