MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for MATCH IT! DNA SOFTWARE 888623 manufactured by Immucor Gti Diagnostics, Inc..
[98179727]
The (b)(6) has reported a complaint ((b)(4)) on (b)(6) 2017 that when using match it! Dna software v1. 2. 3 for hla-a typing, they have observed for 1 sample that the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs (observed with hla-a*02 homozygous samples). The error occurs when using pairwise off with a win 7 32-bit computer, using 3. 27 allele database. When the user navigates from one sample to the next sample, the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences. If the user attempts to make a manual assignment to the assigned view field, the software will crash. During the course of the investigation with the customer, the user's software was updated from v1. 2. 3 to v1. 2. 4. An error still occurs in v1. 2. 4, however in this version the when the user navigates from one sample to the next sample, the software maintains the previous sample typing in the assigned view in addition to the suggested assignments. If the user attempts to make a manual assignment, the software will freeze however there is no warning that the typing in assigned view is incorrect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00001 |
| MDR Report Key | 7207186 |
| Date Received | 2018-01-19 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2017-12-21 |
| Date Added to Maude | 2018-01-19 |
| 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 |
| Removal Correction Number | B-0347-0348-2018 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MATCH IT! DNA SOFTWARE |
| Generic Name | MATCH IT DNA SOFTWARE |
| Product Code | MZI |
| Date Received | 2018-01-19 |
| Catalog Number | 888623 |
| Device Availability | N |
| Device Age | DA |
| 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 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |