MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[77637739]
The investigation determined that non-reproducible higher than expected vitros amon quality control results were obtained from non-vitros control fluids using vitros amon slides on a vitros 5600 integrated system. The most likely cause was user error due to the use of ammonia based cleaners near the system which resulted in incubator contamination. An ortho field engineer (fe) performed an incubator decontamination procedure, including cleaning/replacing the incubator evaporation caps and slots, to return the instrument to expected operation. Following this activity, acceptable vitros amon performance was observed.
Patient Sequence No: 1, Text Type: N, H10
[77637740]
The customer observed non-reproducible higher than expected vitros amon quality control results from a non-vitros control fluid using vitros amon slides on a vitros 5600 integrated system. Biorad level 2 lot 54152 amon results: 131. 5, 109. 8, and 96. 6 umol/l versus expected 68. 8 umol/l. Biorad level 3 lot 54153 amon result 294. 6 umol/l versus expected 222. 4 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected. There were no allegations of patient harm. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00045 |
| MDR Report Key | 6632147 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2017-06-09 |
| 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 |
| 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 | 2017-06-09 |
| 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 | 2017-06-09 |
| 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 | 2017-06-09 |