MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-10 for A HIGH RES SSP UNITRAY W/TAQ10 4729110 manufactured by Life Technologies.
[23600746]
The investigation replicated the customer's observation (b)(6) 2015. The investigation concluded on (b)(6) 2015 and was unable to determine whether the result is related to the specific dna sample or reflective or incorrect labeling on the reactivity for the allele.
Patient Sequence No: 1, Text Type: N, H10
[23600747]
This report is related to customer (b)(4) made against allset gold a high res ssp (sku 54010d, lot 012 1608823), since this lot (listed in c. 6. ) contains the same affected primer mix. The customer reported that the reactivity for lane 86 was negative for the a 03:20 alele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping a a 03:20 allele as an a 03:01 allele.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244574-2015-00083 |
| MDR Report Key | 4912856 |
| Report Source | 05 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-05-22 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2015-07-23 |
| 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 | 2244574-008-2015 C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A HIGH RES SSP UNITRAY W/TAQ10 |
| Generic Name | TEST, QUALITATIVE FOR HLA |
| Product Code | MZI |
| Date Received | 2015-07-10 |
| Catalog Number | 4729110 |
| Lot Number | 012 1467113 1628107 |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES |
| Manufacturer Address | BROWN DEER WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-10 |