MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-20 for LIFECODES HLA-DQA1/B1 SSO TYPING KIT 628930 manufactured by Immucor Gti Diagnostics, Inc..
[114814281]
Customer contacted immucor on (b)(6) 2018 ((b)(4)) regarding a sample in which an allele dropout was suspected with lifecodes hla-dqa1/b1 sso typing kit lot 3004970. The sample was tested and originally resulted in a dqb1 typing of dq5 homozygous with an exact match by the software. The customer suspected a possible allele dropout with the sample and retested the sample with sequence-specific primer (ssp). This resulted in a dqb1 heterozygous typing of dq5/dq9. The sample was then retested by lifecodes sso, resulting in a review probes prompt by the software. The sample required two manual bead changes to result in the heterozygous typing dq5/dq9. The customer stated that they follow immucor product storage and ifu protocols. The incorrect typing was not reported out by the customer. The sample was repeated and the correct results reported out. The customer decided to repeat the sample testing by both ssp and sso due to known gene linkages and also because what the customer considers false negative dq3 probes, were within 30% range from threshold for the sample. The customer will continue to monitor this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00004 |
| MDR Report Key | 7707535 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-20 |
| Date of Report | 2018-01-12 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-12 |
| Device Manufacturer Date | 2017-04-20 |
| Date Added to Maude | 2018-07-20 |
| 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 | ERIKA HEWITT |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541006 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECODES HLA-DQA1/B1 SSO TYPING KIT |
| Generic Name | LIFECODES HLA-DQA1/B1 SSO TYPING KIT |
| Product Code | MZI |
| Date Received | 2018-07-20 |
| Catalog Number | 628930 |
| Lot Number | 3004970 |
| Device Expiration Date | 2018-06-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |