MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-29 for PRISM 6 CHANNEL ANALYZER 06A36-04 manufactured by Abbott Manufacturing Inc.
[4936478]
The customer observed a false (b)(6) hcv result while using the prism hcv assay on the prism analyzer. The customer provided the following data: initial result: (b)(6), this specimen was (b)(6) when tested using a hcv genome method. The lab retested the specimen on a different prism analyzer and the result was (b)(6): (b)(6). The specimen was also (b)(6) using the architect and evolis methods. The tube was decanted and run twice. Again on the original prism analyzer generating (b)(6). There was no adverse impact to patient management reported. No additional patient information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[12237018]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[32505921]
Further evaluation of the customer issue included a review of the complaint text, abbott field service review, review of the instrument service history, a search for similar complaints, and a review of product labeling. An abbott field service engineer (fse) completed troubleshooting of the instrument. This involved part replacements per normal troubleshooting procedures. Review of the instrument service history did not identify any other issues that may have contributed to the current event. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information a product deficiency of the prism instrument, list number 6a36-04, was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2014-00212 |
| MDR Report Key | 4125592 |
| Report Source | 01,05 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-09-05 |
| Date Mfgr Received | 2014-11-05 |
| Device Manufacturer Date | 2003-03-13 |
| Date Added to Maude | 2014-10-07 |
| 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 | 2014-09-29 |
| 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 | 2014-09-29 |