MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-29 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[9699027]
Date received by manufacturer was omitted in the initial report. The date should have been (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
[9844243]
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.
Patient Sequence No: 1, Text Type: N, H10
[21356259]
(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.
Patient Sequence No: 1, Text Type: N, H10
[21418831]
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.
Patient Sequence No: 1, Text Type: D, B5
[26484093]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00794 |
| MDR Report Key | 2392553 |
| Report Source | 05 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-08 |
| Date of Event | 2011-07-08 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-05-25 |
| 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 | 2011-12-29 |
| Catalog Number | 07K35-68 |
| Lot Number | 01157M500 |
| Device Expiration Date | 2011-10-28 |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2011-12-29 |