MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[124697816]
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. The event was isolated to the calibration events performed on (b)(6) 2018 using the same calibrator kit lot 0277. The calibrations were suboptimal when compared to the typical calibration responses and parameters. The most likely cause of the suboptimal calibrations was user error. The customer suspected the calibrator fluids in use were not properly reconstituted due to user error, although this could not be definitively confirmed. Acceptable vitros na+ and k+ performance was observed after a recalibration event was performed using properly handled calibrator fluids.
Patient Sequence No: 1, Text Type: N, H10
[124697817]
The customer obtained higher than expected vitros k+ and na+ results 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. Biorad level 1, lot 47960 na+ results of 143. 0, 142. 7, and 158. 1 mmol/l vs. The expected result of 115. 0 mmol/l. Biorad level 1, lot 47960 k+ result of 3. 70 mmol/l vs. The expected result of 2. 50 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, 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 is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00026 |
| MDR Report Key | 7909694 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2018-09-26 |
| 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 | 2018-09-26 |
| 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 | 2018-09-26 |