MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-24 for LIFECODES HLA-DQA1/B1 SSO TYPING KIT 628930 manufactured by Immucor Gti Diagnostics, Inc..
[114943405]
Customer contacted immucor technical support (complaint #(b)(4)) that samples on the lifecodes hla-dqa1/b1 sso typing kit (628930), lot # 3004970 had discrepant results. Sample was resulting as dqb1*06:09:01:01 homozygous. It was subsequently identified that the sample was not homozygous but found to be dqb1 *06:09:01:01, *03:03:02:01. The customer was not following the product instructions for use (ifu). The customer was not using full volumes of reagents. The customer identified the issue because the obtained results did not fit with the hla-dr associations they should match. The customer repeated the testing with an alternate method (ssp) and discovered a hla-dq6, dq3 result rather than the hla-dq6 homozygote. The customer informed immucor that they performed an investigation to check for patient harm but have found no cause for patient harm. Customer is not following the ifu and was aware of potential risks involved in doing this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00023 |
| MDR Report Key | 7716242 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-24 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-02-09 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2017-04-20 |
| Date Added to Maude | 2018-07-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-07-24 |
| Catalog Number | 628930 |
| Lot Number | 3004970 |
| Device Expiration Date | 2018-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-24 |