MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-27 for PAP-8E 8-E manufactured by Bio/data Corp..
[36914435]
Patient Sequence No: 1, Text Type: N, H10
[36914436]
The laboratory was performing a ristocetin cofactor activity assay and had some issues with quality control. The staff member inadvertently discovered an error in the package insert involving how to make up the blank. The adjustment factor was listed as 1. 5 and should have been 1. 0. We contacted the vendor, bio/data corporation and they stated the correction factor was incorrect. We ceased performance of this test. Manufacturer response for bio/data pap-8e, pap (per site reporter): the vendor confirmed the adjustment factor was incorrect in their reagent package insert. They are issuing a revision to the package insert and will replace reagent used during what we thought were assay issues and during our investigation of the issue. Vendor stated the following in an e-mail: the kits we received were from a single, small batch, all of which was shipped to us. Since the adjustment factor was a constant throughout testing, its effect was limited to shifting the curve. The normal-abnormal breakpoint wasn't affected. The % activity would be somewhat different, but given the nature of the assay, those differences should not have affected clinical decisions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5392697 |
| MDR Report Key | 5392697 |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-11 |
| Date of Event | 2015-12-17 |
| Report Date | 2016-01-11 |
| Date Reported to FDA | 2016-01-11 |
| Date Reported to Mfgr | 2016-01-11 |
| Date Added to Maude | 2016-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAP-8E |
| Generic Name | AGGREGROMETER, PLATELET |
| Product Code | JBX |
| Date Received | 2016-01-27 |
| Model Number | 8-E |
| Lot Number | 34300053 |
| ID Number | VW SELECT (RISTOCETIN COFACTO |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO/DATA CORP. |
| Manufacturer Address | 155 GIBRALTAR RD. HORSHAM PA 19044 US 19044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |