MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-08-31 for MTS INCUBATOR MTS9680 manufactured by Micro Typing Systems, Inc..
[711079]
The customer indicated that, the temperature of the mts incubator was out of specification. Incorrect incubation temperature can lead to false positive and false negative test results, which can lead to transfusion of incompatible blood. Erroneous test results were not reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[7816394]
No definitive root cause could be determined. Assistance provided to the customer over the phone has resolved the issue. This customer has not logged any complaints against this instrument since this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00245 |
| MDR Report Key | 905909 |
| Report Source | 05,06 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-31 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-08-01 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-10-25 |
| 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 | AWILDA GERBER, SCIENTIST |
| Manufacturer Street | 1295 S.W. 29TH AVE. |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239567 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS INCUBATOR |
| Generic Name | MTS GEL CARD INCUBATOR |
| Product Code | JTQ |
| Date Received | 2007-08-31 |
| Model Number | NA |
| Catalog Number | MTS9680 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 903518 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-31 |