MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[80762643]
The investigation determined that a lower and higher than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system. Biorad qc level 2 amon result 103. 7 umol/l versus expected 75. 5 umol/l. Biorad qc level 3 amon result of 15. 7 umol/l versus expected 227. 7 umol/l. The assignable cause of this event was instrument related most likely due to incubator contamination. The customer completed an incubator decontamination procedure including cleaning/replacing the incubator evaporation caps and slots, and returned the instrument to expected operation. Following this activity, acceptable vitros amon performance was observed.
Patient Sequence No: 1, Text Type: N, H10
[80762644]
The customer observed lower and higher than expected vitros amon results when testing non-vitros quality control fluids on a vitros 5600 integrated system. Biorad qc level 2 amon result 103. 7 umol/l versus expected 75. 5 umol/l. Biorad qc level 3 amon result of 15. 7 umol/l versus expected 227. 7 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The vitros amon results were obtained when testing non-vitros quality control samples. However, the investigation cannot conclude that patient samples were not affected or would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00054 |
| MDR Report Key | 6730324 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-24 |
| Date Mfgr Received | 2017-06-19 |
| Device Manufacturer Date | 2012-11-28 |
| Date Added to Maude | 2017-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 0 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2017-07-20 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-20 |
| 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 | 2017-07-20 |