MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[97723714]
The investigation determined that two higher than expected qc results were obtained from a non-vitros quality control fluid when using vitros k+ and vitros na+ reagent lots in combination with a vitros 4600 chemistry system. The most likely assignable cause for the higher than expected results is the use of a sub-optimal calibration event due to calibrator fluids not being reconstituted correctly. Following recalibration using new calibrator fluids, an optimal calibration curve was obtained and there were no additional higher than expected results observed. There is no evidence that would indicate the vitros k+ or na+ slides malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[97723715]
A customer obtained a higher than expected vitros k+ result and a higher than expected vitros na+ result from a non-vitros quality control sample using vitros chemistry products k+ and na+ reagent lots in combination with a vitros 4600 chemistry system. Biorad control l1 vitros k+ result 180 mmol/l versus expected result 113. 5 mmol/l. Biorad control l1 vitros na+ result 6. 49 mmol/l versus expected result 2. 75 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The customer stated there were no patient samples reported from the laboratory over the time frame of the event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00001 |
| MDR Report Key | 7169749 |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-01-05 |
| 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 | 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Generic Name | IN VITROS DIANOSTICS |
| Product Code | JIX |
| Date Received | 2018-01-05 |
| Catalog Number | 1662659 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2019-05-22 |
| 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 | 2018-01-05 |