MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[97815214]
The investigation determined the customer obtained a higher than expected vitros na+ result from a non-vitros quality control fluid processed using vitros chemistry products na+ slides lot 4213-0980-5705 on a vitros 5600 integrated system (s/n (b)(4)). The assignable cause is attributed to user error related to preparation of the calibrator fluids. The customer had reconstituted the calibrator fluids by pouring all of the diluent into the lyophilate. The instructions for use (ifu) for the vitros chemistry products calibrator kit 2 instructs the customer to add 3. 0 ml of the appropriate diluent to each vial. A sub-optimal calibration was obtained for vitros na+ which subsequently generated the unacceptable qc result. Recalibration of vitros na+ with calibrators prepared using the correct protocol has resolved the issue as the post calibration qc results were acceptable. There was no indication that the vitros 5600 integrated system, or the vitros slide lots in use malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[97815215]
A customer observed a higher than expected sodium (na+) result obtained from a non-vitros quality control (qc) fluid, using vitros chemistry products na+ slides processed using a vitros 5600 integrated system. Biorad control lot 45781 vitros na+ result 205 mmol/l versus expected na+ result 113 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho was not made aware of any allegation of patient harm due to the event. However the investigation cannot rule out that patient results were not or would not be affected if the event were to recur undetected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00002 |
| MDR Report Key | 7174345 |
| Date Received | 2018-01-09 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2017-12-18 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2018-01-09 |
| 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 | 2018-01-09 |
| Catalog Number | 1662659 |
| Lot Number | 0257 |
| 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 | 2018-01-09 |