MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-30 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by .
[21944215]
The investigation confirmed that lower than expected vitros valp and vitros gent quality control results were obtained while using the vitros 5600 integrated system. An ocd field engineer performed service actions for unrelated metering issues. Vitros valp and vitros gent reagents were left on board the vitros 5600 integrated system during the time frame that the analyzer was powered off (several hours) for servicing. Lower than expected vitros valp and vitros gent quality control results were obtained after completion of these service activities. According to the vitros valp and gent instructions for use, the on-analyzer stability of the reagent packs is 30 minutes when the system is turned off. Acceptable vitros valp and vitros gent performance was observed with alternate vitros valp and gent reagent packs that were stored under ocd recommended conditions. The assignable cause of the event is a user error. There is no evidence to suggest that the vitros valp, vitros gent reagents or the vitros 5600 integrated system had malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[22197445]
The customer obtained reproducible lower than expected vitros gent and valp quality control results (valp result=0. 0 g/ml versus an expected result= 28. 9 g/ml and gent result=0. 0 g/ml versus an expected result= 6. 305 g/ml) while using the vitros 5600 integrated system. Biased results of the direction and magnitude observed may lead to inappropriate physician action if the event were to occur with patient samples. There was no report of affected patient samples. There were no allegations of harm to patients as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2012-00176 |
| MDR Report Key | 2720985 |
| Report Source | 05 |
| Date Received | 2012-08-30 |
| Date of Report | 2012-08-30 |
| Date of Event | 2012-08-02 |
| Date Mfgr Received | 2012-08-02 |
| Device Manufacturer Date | 2012-04-06 |
| Date Added to Maude | 2012-12-17 |
| 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 | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2012-08-30 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-30 |