MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-13 for B LOCUS SSP UNITRAY 20 TESTS 7870010 manufactured by Life Technologies.
[24524491]
This report is related to customer complaint (b)(4) made against b locus ssp unitray 20 tests (sku 7870010, lot 027 1544274). The customer reported that the reactivity for lane 8 was negative for the b40:08 allele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to the b40:08 allele being missing from the string of many possible alleles. The complaint was confirmed on (b)(6) 2015. The complaint and possible root cause is still under investigation.
Patient Sequence No: 1, Text Type: D, B5
[65725980]
The investigation was concluded on 07/13/21015 and it has been determined to update labeling with the comment "a weak true positive at the correct size (210bp) may be observed with b*40:08 and like samples. " life technologies performed a health hazard evaluation and concluded there was a negligible health hazard. Remedial action initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2244574-2015-00097 |
| MDR Report Key | 4914868 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 2015-04-03 |
| Date Added to Maude | 2015-08-01 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B LOCUS SSP UNITRAY 20 TESTS |
| Product Code | MZI |
| Date Received | 2015-07-13 |
| Catalog Number | 7870010 |
| Lot Number | 027 1544274 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-07-13 |