MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-18 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[5819309]
The account generated false reactive prism chagas results (1. 00, 1. 07, 1. 26 s/co) on a donor who tested ortho chagas eia confirmation negative. No impact to patient management was reported. No specific donor information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13445419]
(b)(4). An evaluation is in process. A followup report will be submitted when the evaluation is complete. Evaluation in process.
Patient Sequence No: 1, Text Type: N, H10
[25341121]
Udi: (b)(4). Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided. The evaluation of complaint data for the product and likely cause lot identified normal complaint activity. Additionally, a review of the device history record for the likely cause lot did not reveal any issues related to the customer's observations. A label review was also performed and found labeling to adequately address the customer's issue. Finally, a review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas product are less than the package insert upper 95% confidence intervals. Based on this investigation, the abbott prism chagas product is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2015-00016 |
| MDR Report Key | 4779724 |
| Report Source | 05 |
| Date Received | 2015-05-18 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-01-31 |
| Date Mfgr Received | 2015-06-10 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-05-19 |
| 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 | 224667-512 |
| 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 |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2015-05-18 |
| Catalog Number | 07K35-68 |
| Lot Number | 41277M500 |
| Device Expiration Date | 2015-04-30 |
| 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 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-18 |