MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-30 for ABBOTT ESA CHAGAS 08L34-68 manufactured by Abbott Laboratories.
[76283643]
Lot/serial number was not provided by the customer; therefore, only a partial udi is known. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[76283744]
The customer reported a blood donor who tested reactive for prism anti-t. Cruzi and was esa chagas positive. The sample was sent for follow-up testing by the cdc for t. Cruzi ab eia and t. Cruzi ab ib (tesa) which were both negative. There was no reported impact to donor management. There was no additional donor information provided.
Patient Sequence No: 1, Text Type: D, B5
[79039065]
Evaluation of complaint data for the list number 8l34 (lot was unknown) identified normal complaint activity and no trends were identified for the abbott esa chagas assay. A review of the manufacturing documentation did not identify any issues associated with the customer observation. A review of the package insert showed that within a study 99. 1% of us blood donors were negative with a 95% confidence interval of 97. 4% to 99. 8%. No sample was false positive within this study, however, it also states, that false reactive test results can be expected with any test kit. Also a study was performed by testing us blood donor samples that were repeat reactive with the prism chagas assay. Some of the samples were also positive on the esa chagas assay, but nonreactive on t cruzi ripa. Based on the data generated during this investigation, the performance of the abbott esa chagas assay is within specifications. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, a systemic issue and/or product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2017-00119 |
| MDR Report Key | 6598065 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-30 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-05-30 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT ESA CHAGAS |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2017-05-30 |
| Catalog Number | 08L34-68 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |