MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[139327218]
The investigation determined that a lower than expected vitros na+ (sodium) result was obtained from a non-vitros (biorad) quality control (qc) fluid when run on a vitros 350 chemistry system. The assignable cause is related to a sub-optimal calibration due to calibrator fluids not being reconstituted correctly. Since the re-calibration using the same lot of reagent, calibrator fluids, and erf resolved the issue, a reagent issue is not likely to be a contributing factor. Although a within run precision test to verify the instrument was not completed, there is no indication of an instrument malfunction.
Patient Sequence No: 1, Text Type: N, H10
[139327219]
A customer obtained a lower than expected vitros na+ (sodium) result from a non-vitros (biorad) quality control (qc) fluid when run on a vitros 350 chemistry system. Non-vitros biorad quality control fluid (lot 47983) na+ result of 138 mmol/l versus an expected result of 166. 2 mmol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros na+ 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 actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00009 |
| MDR Report Key | 8409521 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2019-03-11 |
| 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 DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2019-03-11 |
| Catalog Number | 1662659 |
| Lot Number | 0288 |
| 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 | 2019-03-11 |