MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-08 for MTS ANTI-IGG, -C3D CARD MTS4014 manufactured by Micro Typing Systems, Inc,.
[1153631]
The customer reported that a dat positive sample failed to react in the mts anti-igg, -c3d card lot# 071608005-04. The sample reacted positive (1+) using the mts anti-igg card. A false negative dat may lead to confusion in the diagnosis of anemia or misdiagnosis of a hemolytic transfusion reaction.
Patient Sequence No: 1, Text Type: D, B5
[8310957]
Satisfactory results were obtained at ocd using retained cards from mts anti-igg - c3d card lot # 071608005-04 and mts anti-igg card lot # 112408001-30 using known dat positive and negative samples. The gel cards performed as expected at ocd. The customer's complaint was not confirmed. The sample in question was submitted to ocd for add'l testing. A definite root cause was not determined regarding the negative results obtained at the customer site. A complaint review indicated no other complaints have been logged against lot# 071608005-04. Batch record review was within release specifications. Incident is isolated. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2009-00097 |
| MDR Report Key | 1458586 |
| Report Source | 05,06 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-05-07 |
| Date of Event | 2009-04-14 |
| Date Mfgr Received | 2009-04-14 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2010-05-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER SPARROW |
| Manufacturer Street | 1001 US ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9087043872 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS ANTI-IGG, -C3D CARD |
| Generic Name | ANTI-HUMAN GLOBULIN REAGENT |
| Product Code | CFQ |
| Date Received | 2009-05-08 |
| Model Number | NA |
| Catalog Number | MTS4014 |
| Lot Number | 071608005-04 |
| ID Number | NA |
| Device Expiration Date | 2009-08-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO TYPING SYSTEMS, INC, |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-08 |