MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[69259519]
The investigation determined that higher than expected vitros na+ results were obtained on a vitros 5600 integrated chemistry system. The most likely assignable cause of the higher than expected vitros na+ result is a sub-optimal calibration event that occurred on (b)(6) 2017. Following recalibration with a new set of calibrator kit 2 fluids, the customer? S calibrator parameters compared well to the expected values and subsequent qc results were within range. A definitive assignable cause for the sub-optimal calibration could not be determined. A reconstitution error when preparing the calibrator kit cannot be ruled out or confirmed as the cause of the suboptimal calibration. There was no evidence to suggest that vitros na+ reagent lot 4206-0961-7450 or the vitros 5600 integrated system malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[69259520]
A customer obtained higher than expected vitros na+ results when testing a quality control fluid on a vitros 5600 integrated chemistry system. Vitros na+ result 135. 0 mmol/l versus expected result of 118. 1 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected vitros na+ result was from a quality control fluid. No patient results were affected. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00006 |
| MDR Report Key | 6374427 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2017-03-02 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2017-03-02 |
| Catalog Number | 1662659 |
| Lot Number | 0226 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2017-07-18 |
| 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 | 2017-03-02 |