MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[99789906]
The investigation determined that higher than expected vitros sodium (na+), creatinine (crea), and calcium (ca) results were obtained from a non-vitros quality control fluid and a patient sample when processed using vitros microslides a vitros 5600 integrated system. The most likely assignable cause for the higher than expected results for the three vitros microslide assays was related to sub-optimal calibration parameters. The assignable cause of the suboptimal calibrations was unknown. The laboratory obtained acceptable quality control performance following recalibration of the affected assays (na+, crea, ca) and an e-connectivity review of the data has confirmed that acceptable assay performance has been maintained. Since the post-calibration results are within expectations, a reagent issue was not likely to be a contributing factor. Within run precision tests and quality control data show the vitros instrument was not meeting expectations. However, the magnitude of the biases due to the instrument issue do not correlate with the biases observed. Therefore, while an instrument issue is not a likely contributing factor to the event, it cannot be entirely ruled out.
Patient Sequence No: 1, Text Type: N, H10
[99789907]
The customer reported that higher than expected vitros sodium (na+), creatinine (crea), and calcium (ca) results were obtained from a non-vitros quality control fluid and a patient sample when processed using vitros microslides a vitros 5600 integrated system. Non-vitros biorad quality control fluid (lot 45781) na+ result of 250 mmol/l versus an expected result of 112. 7 mmol/l. Crea patient result of 2. 2 mg/dl versus an expected result of 1. 49 mg/dl non-vitros biorad quality control fluid (lot 45781) ca results of 10. 59 and 10. 62 mg/dl versus an expected result of 6. 21 mg/dl. 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 crea patient result was reported outside the laboratory. It is not known if treatment was altered, initiated or stopped based upon the reported results. Ortho is not aware of any allegation of patient harm as a result of the event. This report is number 1 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00006 |
| MDR Report Key | 7242930 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-05 |
| Date of Event | 2017-12-28 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-02-05 |
| 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 | 2018-02-05 |
| Catalog Number | 1662659 |
| Lot Number | 267 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2019-05-22 |
| 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 | 2018-02-05 |