MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-05-04 for PRISM 6 CHANNEL ANALYZER 06A36-04 manufactured by Abbott Manufacturing Inc.
[5887127]
The customer stated that (b)(6) prism anti-hcv results were generated. An initial (b)(6) prism hcv result of (b)(6) was generated. The sample was repeated in duplicate on the same analyzer and (b)(6) results of (b)(6) and (b)(6) were generated. (b)(6) results were generated with biorad eia hcv, innolea hcv and viral load testing. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[13264699]
(b)(4). A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[35078923]
The customer observed (b)(6) prism hcv results with lot 44562li00 on the prism analyzer using reaction tray lot 43289m500. Testing was performed across three runs (two instruments) using one replicate of negative calibrator at the end of each run. All negative calibrator replicates were non-reactive, thus indicating the product is performing as expected. A malfunction was not identified as the issue occurred for a single patient, and the abbott prism hcv assay has a stated specificity claim of greater than or equal to 99. 73%. Customer complaint data was reviewed and no related adverse trends and no non-statistical trends were identified for the complaint issue. A review for non-conformances and deviations was performed and none were found. The prism hcv reagent package insert and the prism operations manual were reviewed and were found to adequately address the issue. The investigation did not identify a malfunction / deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00145 |
| MDR Report Key | 4746792 |
| Report Source | 01,05 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-05-13 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM 6 CHANNEL ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | MZP |
| Date Received | 2015-05-04 |
| Catalog Number | 06A36-04 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |