MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-24 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[109636665]
The donorscreen-hla class i and class ii assay is used by a laboratory group, (b)(4) which has several sites in the united states. Cts reported an hla class ii result discrepancy between testing performed at 2 sites, (b)(4). The sample was a fresh sample, never frozen, drawn on (b)(6) 2018 in 2 seperate tubes which was refrigerated until (b)(6) 2018 for testing. Testing was performed on (b)(6) 2018. The testing was performed at both sites about an hour apart. Discrepancy in results for two samples between the sites was reported. There is conflict in the information from the customer where the customer stated one sample was affected but data and some description provided by customer is that two samples were affected. The hla class i results were negative for the samples at both sites. Site: quickstep serial #: sample id: result: result reported kit lot #: 1, (b)(4) , (b)(4) - ( neg), no, 3006245a/b. 2, (b)(4), (b)(4) + (pos), yes, same. 1, (b)(4), (b)(4) - ( neg), no, same. 2, (b)(4), (b)(4) + (pos), yes, same. The customer stated that their qa department determined the pos (positive) result would be reported for this sample. Four contacts with the customer who placed the complaint were attempted. As of this report, response has still not been received from the contact at the customer site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00012 |
| MDR Report Key | 7542214 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-24 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2018-01-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | DONORSCREEN-HLA CLASS I AND CLASS II |
| Generic Name | TEST, HLA PRODUCT CODE: MZI |
| Product Code | MZI |
| Date Received | 2018-05-24 |
| Catalog Number | DSI+II |
| Lot Number | 3006245A/B |
| Device Expiration Date | 2019-08-15 |
| 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 |