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..
[109619122]
User laboratory notified immucor gti diagnostics that they used components from 2 lots of product during 3 testing runs. The mistake was identified during the third run which was aborted. The samples from this third run were repeated using kit components from one lot of product. The two prior runs, samples which resulted as positive were regarded as such and the blood products which the testing was performed on were discarded. Samples which originally resulted as negative were repeated using components from one lot of product. One sample which originally resulted as negative in turn resulted as positive. The blood product which the sample was from was able to be 'recalled' and it was destroyed. Immucor complaint number for report by customer was (b)(4). No patient harm occurred. Regulatory reporting was not performed at the time of the event. This event was categorized as not requiring mdr reporting. A review of potential events during 2017 was performed in january 2018. At that time, it was identified that due to this being user incorrect performance of an assay leading to a false negative result, an mdr would be submitted. The product lots used were: 3004096a and 3004609a. The date of the event as experienced by the user laboratory is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00009 |
| MDR Report Key | 7542131 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-24 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-08-25 |
| 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 | 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 |
| Date Received | 2018-05-24 |
| Model Number | NA |
| Catalog Number | DSI+II |
| Lot Number | 3004096A |
| Device Expiration Date | 2018-03-15 |
| 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 | 1. Other | 2018-05-24 |