MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-05-24 for LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT 628915 manufactured by Immucor Gti Diagnostics, Inc..
[109635202]
Customer complaint was received on march 2, 2018 ((b)(4)) describing that when reports were generated using product number 628915, lot number 01117a of lifecodes hla-b sso typing kit the serological equivalent for b*27:08 was shown to be bw4 rather than the correct bw6. Immucor gti diagnostics quality control reviewed the complaint and discovered that the change was due to a transcription error during creation of hla-b probe hit tables for 3. 29. 0 allele database serological equivalence file of the database files. The hla-b allele b*27:08 serological equivalence changed from a b27 (bw6) in allele database 3. 27. 0 to b2708 (bw4) in allele database 3. 29. 0. The hla-b allele b*27:08 serological equivalence was incorrectly assigned bw4. An ncr (ncr 1762) was opened to address the issue. Resolution of this error was made with a correction to the database, a customer notification (correction) and a technical update loaded to the immucor website for the affected lots of product. The serological equivalent (bw4 or bw6) is assigned by the world health organization (who). Lifecodes hla sso-b typing kit or lifecodes hla sso-beres affected kits: product name: lifecodes hla-b sso typing kit, lot#/serial #: 01117a, list # part#: 628915, expiration date: 2018-11-30; lifecodes hla-b sso typing kit, 06036a, 628915, 2018-05-31; lifecodes hla-beres sso typing kit, 01117b, 628917, 2018-12-31; lifecodes hla-beres sso typing kit, 06036b, 628917, 2018-12-31. The lifecodes hla sso-b and hla sso-b eres typing kits are meeting performance claims. This issue is a documentation error not associated with a performance claim or who standard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00011 |
| MDR Report Key | 7542142 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-24 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2017-03-16 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT |
| Generic Name | QUALITATIVE TEST FOR HLA, NON-DIAGNOSTIC |
| Product Code | MZI |
| Date Received | 2018-05-24 |
| Catalog Number | 628915 |
| Lot Number | 01117A |
| Device Expiration Date | 2018-11-30 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2018-05-24 |