MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-28 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[98733985]
The investigation determined that a higher than expected k+ result was obtained from a non-vitros biorad quality control fluid using vitros potassium (k+) microslides on a vitros 5600 integrated system. The higher than expected result was obtained following a calibration event where it was determined the calibration parameters were suboptimal. The assignable cause of the suboptimal calibration is unknown. Acceptable k+ quality control performance was obtained after a recalibration of the vitros k+ slide lot using an alternate calibrator kit lot was performed. There is no indication of a vitros k+ reagent issue or an instrument issue.
Patient Sequence No: 1, Text Type: N, H10
[98733986]
The customer obtained a higher than expected vitros k+ result (4. 08 mmol/l vs. Expected 2. 72 mmol/l) from a single non-vitros biorad lot 45770 quality control fluid processed using vitros k+ microslides on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros k+ result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results were not affected and 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00005 |
| MDR Report Key | 7224046 |
| Date Received | 2018-01-28 |
| Date of Report | 2018-01-28 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-01-01 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2018-01-28 |
| 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 VITRO DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2018-01-28 |
| Catalog Number | 1662659 |
| Lot Number | 236 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2018-12-19 |
| 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 | 2018-01-28 |