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.
[6049973]
This report is related to customer complaint (b)(4) made against allset gold a high res ssp ((b)(4), lot 012 1608823), since this lot contains the same affected primer mix. The customer reported that the reactivity for lane 86 was negative for the a 03:20 allele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping an a 03:20 allele as an a 03:01 allele.
Patient Sequence No: 1, Text Type: D, B5
[13971011]
The investigation replicated the customer's observation (b)(6) 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. The customer performed sso typing and dna sequencing and observed a conflict with the results obtained with allset gold a high res ssp ((b)(4) lot 012 1608823. 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 for the affected alleles are minimal to non-existent. In addition, the affected allele is very rare 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
| Report Number | 2244574-2015-00096 |
| MDR Report Key | 4912918 |
| Report Source | 05 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-05-22 |
| Device Manufacturer Date | 2015-01-07 |
| Date Added to Maude | 2015-07-29 |
| 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 1648453 |
| Device Expiration Date | 2016-06-30 |
| 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 |