MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-24 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[75858795]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Additional information suspect medical device; concomitant: abbott esa chagas; list # 08l34-68; lot # a00001300.
Patient Sequence No: 1, Text Type: N, H10
[75858796]
The customer reported increase in (b)(6) prism chagas and prism hcv results in (b)(6)2017. Of 14 rr chagas samples 7 were (b)(6). Supplemental/confirmatory testing was performed with ortho chagas (2 (b)(6), 5 not tested); ortho hcv all 7 (b)(6); abbott chagas esa (6 (b)(6), one not tested). There was no reported impact to donor/patient management. There was no additional donor information provided.
Patient Sequence No: 1, Text Type: D, B5
[78998504]
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 indicates that the initial and repeat reactive rates for the abbott prism chagas lot 68048m500 which is less than the package insert's upper 95% confidence intervals. Labeling claims were met for specificity; there is no product deficiency. A malfunction was not identified. Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2017-00114 |
| MDR Report Key | 6587614 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-24 |
| Date of Report | 2017-06-07 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-05-24 |
| 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 | 2017-05-24 |
| Catalog Number | 07K35-68 |
| Lot Number | 68048M500 |
| Device Expiration Date | 2017-06-25 |
| 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 | 2017-05-24 |