MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-24 for LIFECODES HLA-DQA1/B1 SSO TYPING KIT 628930 manufactured by Immucor Gti Diagnostics, Inc..
[109627091]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109627092]
Immucor received a customer complaint on 26 february 2018 ((b)(4)) from a customer that contacted immucor regarding eight samples across three runs that generated a mistype with lifecodes hla-dqa1/b1 sso typing kit (lot 3006117). The customer reports that for these samples the dqa probe 207 was false negative resulting in dqa sample mistype for dqa1*02. In all cases, the samples were typed as dqa1*01 homozygous by lifecodes hla-dqa1/dqb1 sso typing kit lot 3006117. The samples were repeated for dqa locus by the customer on ssp/linkseq and the repeat typing results were dqa1*01, dqa1*02. The customer informed immucor that no incorrect results were reported. The customer chose to repeat the typings by another method due to probe 207 being close to the threshold and due to known gene associations with drb1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00010 |
| MDR Report Key | 7542134 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-24 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-02-26 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULIE EWEND |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541009 |
| 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 | 2018-05-24 |
| Catalog Number | 628930 |
| Lot Number | 3006117 |
| Device Expiration Date | 2019-06-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-24 |