MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-21 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[60624375]
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
[60624376]
The account generated false repeatedly reactive prism chagas results on 20 donors that tested esa chagas negative since may 2016. Additionally, 5 donors were prism chagas were repeatedly reactive but no confirmatory testing was available since january 2016. No impact to patient management was reported. No specific donor information was available.
Patient Sequence No: 1, Text Type: D, B5
[65845940]
Evaluation of complaint data for the products and likely cause lot identified normal complaint activity. Additionally, review of the device history records for the likely cause lot did not reveal any issues related to the customer's observations. Label reviews were also performed and found them to adequately address the customer's issue. Finally, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas products are less than the package insert upper 95% confidence intervals. Therefore, the lots are meeting labeling claims for clinical specificity. There is no malfunction or product deficiency. The abbott prism chagas products are performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00114 |
| MDR Report Key | 6118917 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-21 |
| Date of Report | 2017-01-17 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-11-21 |
| 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 | 2016-11-21 |
| Catalog Number | 07K35-68 |
| Lot Number | 62078M500 |
| Device Expiration Date | 2016-12-04 |
| 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 | 2016-11-21 |