N
Patient 1
DATE RECEIVED BY MANUFACTURER WAS OMITTED IN THE INITIAL REPORT. THE DATE SHOULD HAVE BEEN (B)(4) 2011.
MAUDE MDR 2392553
- MDR report key
- 2392553
- Report number
- 1415939-2011-00794
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-07-08
- Date received
- 2011-12-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NOEMI ROMERO-KONDOS, RN BSN
- Address
- 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
- Phone
- 847-847-8479
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRISM CHAGAS | ABBOTT LABORATORIES | MIU | 07K35-68 | 01157M500 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-12-29 | 0 |
Event Narratives#
N
Patient 1
FIELD DATA REVIEW; FALSE POSITIVE RESULT. CLINICAL SPECIFICITY WAS EVALUATED BY COMPLETING A REVIEW OF FIELD DATA REPORTED TO OUR PRISM METRICS DATABASE FROM CUSTOMERS USING THE PRISM HCV ASSAY. (B)(4). CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE PRISM HCV REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE CUSTOMER WAS REFERRED TO THE LIMITATIONS OF PROCEDURE SECTION REGARDING FALSE REACTIVE RESULTS. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ABBOTT PRISM HCV ASSAY (LIST NUMBER 6D18) IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.
N
Patient 1
(B)(4) - (NO CONSEQUENCES OR IMPACT TO PATIENT). (B)(4) - ((B)(6) RESULT). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
D
Patient 1
THE ACCOUNT STATED THAT (B)(6) PRISM CHAGAS RESULTS WERE GENERATED ON A DONOR SAMPLE. THE INITIAL RESULT (B)(6) WITH REPEAT RESULTS OF (B)(6). CHAGAS CONFIRMATORY TESTING (METHOD UNKNOWN) WAS PERFORMED AND WAS (B)(6). (B)(6) TESTING WAS (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.
N
Patient 1
THIS REPORT IS A CORRECTION TO FOLLOW UP REPORT -02. CLINICAL SPECIFICITY WAS EVALUATED BY COMPLETING A REVIEW OF FIELD DATA REPORTED TO OUR PRISM METRICS DATABASE FROM CUSTOMERS USING THE PRISM CHAGAS ASSAY. THE PRISM CHAGAS INITIAL REACTIVE RATE RANGED FROM 0.09% TO 0.26%, AND THE REPEAT REACTIVE RATE RANGED FROM 0.08% TO 0.16%. THESE RESULTS WERE LESS THAN THE PRISM CHAGAS PACKAGE INSERT UPPER 95% CONFIDENCE INTERVALS OF 0.28% FOR THE INITIAL REACTIVE RATE AND 0.23% OF THE REPEAT REACTIVE RATE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE PRISM CHAGAS REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE CUSTOMER WAS REFERRED TO THE LIMITATIONS OF PROCEDURE SECTION REGARDING FALSE REACTIVE RESULTS. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ABBOTT PRISM CHAGAS ASSAY (LIST NUMBER 7K35-68) IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.