MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-09-04 for MTS DILUENT 2 PLUS MTS9325 manufactured by Micro Typing Systems, Inc..
[921657]
The customer reported that they obtained false positive results with the mts a/b/d monoclonal, and reverse grouping card lot # 101007037-27, with 2 patient samples. The customer indicated the patients were typed as group a positive, with the anti-b and control microtubes appearing as weakly positive reactions. The customer suspected the mts diluent 2 plus lot # 012-189 used in preparation of the cell suspensions was contaminated. No erroneous results were reported.
Patient Sequence No: 1, Text Type: D, B5
[8196952]
It is unk how the diluent became contaminated. The customer indicated they obtained acceptable results when the samples were repeated using the same lot of gel cards, and a newly opened diluent bottle from the same lot. The customer also indicated that the dispenser, that was previously involved in testing, was not used during repeat testing. Therefore, contaminated dispenser may have contributed to this incident. Review of manufacturing documents indicates that this product passed all release criteria. The customer did not report of particulates or any abnormal appearance in the diluent bottle prior to use. A complaint review indicated no other complaints have been logged against this lot of diluent. Incident is isolated. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2008-00278 |
| MDR Report Key | 1156266 |
| Report Source | 05,06 |
| Date Received | 2008-09-04 |
| Date of Report | 2008-09-04 |
| Date of Event | 2008-08-06 |
| Date Mfgr Received | 2008-08-06 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2010-04-12 |
| 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 DILUENT 2 PLUS |
| Generic Name | RED BLOOD CELL DILUENT |
| Product Code | KSG |
| Date Received | 2008-09-04 |
| Model Number | NA |
| Catalog Number | MTS9325 |
| Lot Number | 012-189 |
| ID Number | NA |
| Device Expiration Date | 2009-01-04 |
| 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 | POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-04 |