MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[40080905]
The investigation determined that 45 higher than expected amon results were obtained from both ortho and non-ortho biorad quality control fluids on a vitros 5600 integrated system the most likely assignable cause is an instrument issue related to incubator contamination based on pre-service within run precision testing performance higher than the guideline and acceptable post-service precision. An ortho field engineer performed service actions on the microslide incubator and replaced the evaporation caps, belt and wear pads. Following completion of maintenance actions significantly improved vitros amon precision performance was achieved using the same vitros amon reagent lot.
Patient Sequence No: 1, Text Type: N, H10
[40080906]
A customer obtained 45 higher than expected vitros amon results from ortho and non-ortho biorad quality control fluids using vitros amon slide lot 1014-0239-3216 tested on a vitros 5600 integrated system. Vitros lpv i results of 90. 7 umol/l compared to an expected result of 45. 1 umol/l. Vitros lpv ii result of 256. 3 umol/l compared to an expected result of 199. 2 umol/l. Biorad liquicheck quality control fluid (lot#51962) results of 129. 6, 126. 5, 126. 1, 123, 122. 2, 121. 4, 121. 4, 121. 2, 120. 1, 119. 7, 118. 1, 117. 7, 116. 1, 115. 7, 112. 7, 111. 2, 111, 108. 9, 100. 4, 99. 1, 99, 98. 8, 97. 3, 97. 1, 115. 3, 131. 4, 128. 1, 127, 122. 1, 121, 120, 119. 5, 119. 2, 118. 7, 115. 1, 114. 9, 110. 1, 106. 6, 105. 2, 103, 100. 3, 99. 3, 96. 2 umol/l compared to an expected result of 80 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho has not been made aware of any erroneous vitros amon results obtained or reported from the laboratory during the time frame of this event. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2016-00042 |
| MDR Report Key | 5485394 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-11 |
| Device Manufacturer Date | 2014-09-12 |
| Date Added to Maude | 2016-03-08 |
| 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 | 2016-03-08 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-08 |