MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-28 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[118576184]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data reactive rates, and a sensitivity and specificity review. No adverse trend was identified for the issue. Labeling was reviewed and found to be adequate. Both specificity and sensitivity reviews met all specifications. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[118576185]
During a clinical evaluation study using prism chagas as the predicate product, a donor specimen tested on prism was found to be discordant relative to another supplemental method being used for final result interpretation. Two false non-reactive samples on the prism chagas assay for samples w14091712737300 and w14091801031634 were identified during the course of the study. The donor was deferred and the blood product was destroyed; there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00122 |
| MDR Report Key | 7824143 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-08-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-08-28 |
| Catalog Number | 07K35-68 |
| Lot Number | 78049M500 |
| Device Expiration Date | 2018-05-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-28 |