MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-12 for MTS INCUBATOR MTS9680 manufactured by Micro Typing Systems, Inc..
[870908]
The customer reported that they obtained a false antibody screen result with a pt's sample on the mts incubator. The customer performed investigation and indicated that their biomed had accidentally knocked the power cord out of the mts incubator shortly after a gel rack had been inserted. The tech failed to notice the out of range incubator light (incubator power was off) when the incident occurred. The pt visited the facility 7 days later for transfusion and the discrepancy was noted upon repeat testing for blood work up.
Patient Sequence No: 1, Text Type: D, B5
[8083617]
A possible root cause was determined. The customer's biomed tech inadvertently knocked the power cord out of the incubator causing the incubator power cord out of the incubator causing the incubator power to be off. Since the power was off, the gel card in question was not incubated at the correct temperature, resulting in the false negative results. Repairs were not required since instrument malfunction did not occur. User error could not be ruled out as a contributing factor. The customer indicated it is now required by their staff to inspect the power cord at the beginning of each shift. Incident is isolated. This customer has not logged any complaints against this instrument since this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2008-00198 |
| MDR Report Key | 1060814 |
| Report Source | 05,06 |
| Date Received | 2008-06-12 |
| Date of Report | 2008-06-12 |
| Date of Event | 2008-05-19 |
| Date Mfgr Received | 2008-05-19 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2008-11-24 |
| 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 |
| 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 | 9087043874 |
| 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 | 2008-06-12 |
| 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 | 1288999 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-12 |