MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-30 for DPBI SSP UNITRAY W/TAQ 12 TEST 451616D manufactured by .
[21843297]
This report is related to customer complaint (b)(4) made against another product, dpbi ssp unitray 12 tests (sku 451606d, lot 009 1464121). The customer reported that the reactivity for lanes 13, 27,, 30, 39 and 40 was negative for the dpbi 99:01 allele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping a dpbi 99:01 allele as a dpbi 39:01 allele. The complaint has been confirmed and in addition to the product against which the complaint was lodged, it was found that product 451616d dpbi ssp unitray w/taq 12 test lot 009 1608871 1684500, the subject of this report, was impacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244574-2015-00068 |
| MDR Report Key | 4648958 |
| Report Source | 07 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-03-04 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2015-05-12 |
| 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 | THOMAS TYRE |
| Manufacturer Street | 9099 NORTH DEERBROOK TRAIL |
| Manufacturer City | BROWN DEER WI 53223 |
| Manufacturer Country | US |
| Manufacturer Postal | 53223 |
| Manufacturer Phone | 4142144025 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Removal Correction Number | 2244574-004-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DPBI SSP UNITRAY W/TAQ 12 TEST |
| Generic Name | MZI TEST, QUALITATIVE FOR HLA |
| Product Code | MZI |
| Date Received | 2015-03-30 |
| Catalog Number | 451616D |
| Lot Number | 009 1608871 1684500 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-30 |