MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[126236711]
The investigation determined that higher than expected vitros k+ and na+ results were obtained from a non-vitros biorad level 1 quality control fluid processed using vitros k+ and na+ slides in combination with a vitros 5600 integrated system and a vitros 4600 chemistry system. The assignable cause was most likely atypical calibrations. The calibrations were suboptimal when compared to typical calibration responses and parameters with responses from level 3 of the calibrator for both instruments being higher than the database. The issue was resolved by recalibrating with freshly reconstituted calibrator vials and using the same vitros na+ and vitros k+ reagent lots. The historical quality control results indicate both the vitros na+ lot and vitros k+ lot in combination with both the vitros 5600 and vitros 4600 systems were performing as expected. There is no indication of a reagent issue or an instrument issue.
Patient Sequence No: 1, Text Type: N, H10
[126236712]
A customer reported higher than expected qc results obtained using vitros potassium (k+) slides and vitros sodium (na+) slides on a vitros 5600 integrated system and a vitros 4600 chemistry system. Non-vitros biorad quality control fluid level 1 (lot 45771): vitros k+ result on vitros 5600 3. 59 mmol/l versus expected vitros k+ result 2. 72 mmol/l; vitros k+ result on vitros 4600 3. 60 mmol/l versus expected vitros k+ result 2. 72 mmol/l; vitros na+ result on vitros 5600 149. 8 mmol/l versus expected vitros na+ result 118. 1 mmol/l; vitros na+ result on vitros 4600 147. 7 mmol/l versus expected vitros na+ result 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 unexpected vitros na+ and k+ results were generated from non-patient fluids and there was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00041 |
| MDR Report Key | 7994158 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2017-12-11 |
| Date Added to Maude | 2018-10-23 |
| 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 | 2018-10-23 |
| Catalog Number | 1662659 |
| Lot Number | 0277 |
| Device Expiration Date | 2019-12-11 |
| 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 | 2018-10-23 |