MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-26 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[76164130]
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
[76164131]
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
[78999065]
Evaluation of complaint data for the lots identified normal complaint activity. A review of the manufacturing documentation did not identify any issues associated with the customer observation. Labeling was reviewed and found to adequately address the issue. A review of the prism metrics field data for the abbott prism chagas lot 68048m500 was performed for specificity. A total of 443,845 samples were tested across multiple customer sites and the initial and repeat (b)(4), respectively, which are less than the prism chagas package insert upper 95% confidence intervals of 0. 28% and 0. 23%. Therefore, the lot is meeting labeling claims for clinical specificity. 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 | 1415939-2017-00117 |
| MDR Report Key | 6594069 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-26 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-05-26 |
| 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 | PRISM CHAGAS |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2017-05-26 |
| Catalog Number | 07K35-68 |
| Lot Number | 66035M500 |
| Device Expiration Date | 2017-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-26 |