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 ALLSET GOLD A HIGH RES SSP 54010D manufactured by Life Technologies.
[22409550]
The investigation replicated the customer's observation 06/09/2015. The investigation concluded on 06/16/2015 and was unable to determine whether the result is related to the specific dna sample or reflective of incorrect labeling on the reactivity for the allele. Life technologies used a retain kit and tested a sample returned by the customer in ssp analysis. Results were obtained on 06/09/2015. The clinical consequences of a mis-type of the affected alleles are minimal to non-existent. In addition, the affected allele is very rate in the general population and is expected to be in less than 0. 01% of the dna samples tested.
Patient Sequence No: 1, Text Type: N, H10
[22409551]
This report is related to customer complaint (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 a03:20 allele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping an a03:20 allele as an a03:01 allele.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244574-2015-00094 |
| MDR Report Key | 4912952 |
| Report Source | 05 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-05-22 |
| Device Manufacturer Date | 2014-09-11 |
| Date Added to Maude | 2015-07-24 |
| 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 | ALLSET GOLD A HIGH RES SSP |
| Generic Name | MZI TEST, QUALITATIVE FOR HLA |
| Product Code | MZI |
| Date Received | 2015-07-10 |
| Catalog Number | 54010D |
| Lot Number | 012 1608903 |
| 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 |
| Manufacturer | LIFE TECHNOLOGIES |
| Manufacturer Address | BROWN DEER WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-10 |