MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-12 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[3807541]
The customer reports three falsely reactive prism chagas assay results on donor samples. The three samples tested negative by ripa confirmation testing. The customer could not provide any individual specific donor testing information. The customer noted that their initial reactive (0. 32%)and repeat reactive rates (0. 23%) for (b)(6) 2013, exceeded assay package insert claims of 0. 28% and 0. 22% respectively. The customer noted that there were no changes in their testing process. The majority of samples were fresh serum with possibly a few fresh plasma samples. All donors were being tested for the first time for chagas. The customer stated that the current and previous reagent lots have had no issues and are performing as expected. No suspect results had been reported from the lab with no donor impact.
Patient Sequence No: 1, Text Type: D, B5
[11094119]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[26492631]
Further investigation of the customer issue included a review of historical and complaint data, a review of device history records, review of labeling and review of field clinical specificity data. Review of the data did not identify any product issue or adverse trend. Labeling was reviewed and found to be adequate. An analysis of the field data reported to the prism metrics database for abbott prism chagas reagent lot 23242m501 and base lot 23242m500, which contains the same material contributing to product performance was analyzed. A total of (b)(4) samples had been tested for these lots across multiple customer sites at the time of the review. The overall initial and repeat reactive rates were calculated to be 0. 15% and 0. 12%, respectively. These initial and repeat reactive rates were less than the abbott prism chagas package insert ((b)(4)) upper 95% confidence intervals of 0. 28% and 0. 23%, respectively. As a result, the lot is meeting labeling claims for clinical specificity. Based on the results of this investigation, no malfunction or deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00337 |
| MDR Report Key | 3344819 |
| Report Source | 05 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-08-20 |
| Date Mfgr Received | 2013-09-30 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM CHAGAS |
| Product Code | MIU |
| Date Received | 2013-09-12 |
| Catalog Number | 07K35-68 |
| Lot Number | 23242M501 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-12 |