MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2012-02-28 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[2391294]
The customer obtained imprecise vitros phyt results while using the vitros 5600 integrated system. The imprecise vitros phyt results were obtained across three different reagent lots during daily quality control testing and while running investigative precision tests. A value of 47. 2 umol/l (expected = 28. 7 umol/l) was obtained from the biorad level 1 fluid. A value of 92. 4 umol/l (expected = 56. 7 umol/l) was obtained from the biorad level 2 fluid. Values of 136. 6, 143. 4, 156. 9, 124. 8, and 136. 4 umol/l (expected = 102. 3 umol/l) were obtained from the biorad level 3 fluid. Values of 148. 1, 156. 9, 135. 9, and > 158. 4 umol/l (expected = 112. 9 umol/l) and values of 145. 1 and > 158. 4 umol/l (expected = 108. 9 umol/l) were obtained from the vitros tdm pv iii fluid. Values of > 158. 4 umol/l (expected = 118. 3 umol/l) and > 158. 4 umol/l (expected = 128. 2 umol/l) were obtained from unknown fluids used for precision testing. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9607226]
The investigation determined that imprecise vitros phyt results were obtained while using the vitros 5600 integrated system. Results of precision testing suggested that the vitros 5600 integrated system was not performing as expected at the time of the event. An ocd field engineer cleaned the incubator, replaced the evaporation caps and insert blade, and performed relevant subsystem adjustments to return the instrument to expected operation. Following these service activities, acceptable vitros phyt performance was observed. There was no evidence to suggest a malfunction of the vitros phyt reagent. The most likely root cause of this event is instrument related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00024 |
| MDR Report Key | 2471223 |
| Report Source | 00,01,05 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-01-08 |
| Date Mfgr Received | 2012-01-30 |
| Device Manufacturer Date | 2010-10-08 |
| Date Added to Maude | 2012-04-12 |
| 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 | 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 | DKH |
| Date Received | 2012-02-28 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-28 |