MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-12-20 for VITROS CHEMISTRY PRODUCTS CA SLIDES 1450261 manufactured by Ortho-clinical Diagnostics.
[131921936]
The investigation determined that higher than expected vitros calcium (ca) results were obtained from a single (b)(6) external quality control (qc) sample processed on a vitros 5,1 fs chemistry system. The assignable cause for this event is unknown, however, the issue is isolated to the affected (b)(6), (b)(6) 2018 sample. The higher than expected vitros ca results obtained were reproducible, indicating a sample related issue. However, 63 of 64 vitros users obtained acceptable results from the same sample, therefore, a sample-matrix issue did not likely contribute to the event. However, a sample related issue isolated to the affected sample at this site cannot be ruled out as contributing to the event. Historical vitros ca qc results and vitros ca within-run precision test results obtained from vitros ca slide lot 0305-0560-5594 tested on the vitros 5,1 fs system were acceptable. This would indicate the vitros 5,1 fs system and vitros ca slide lot 0305-0560-5594 did not malfunction. Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros product ca slide lot 0305-0560-5594. A definitive assignable cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[131921937]
A customer obtained higher than expected vitros calcium (ca) results from a single ((b)(6)) external quality control (qc) sample processed on a vitros 5,1 fs chemistry system. (b)(6) ,(b)(6) 2018 sample vitros ca results of 9. 31 and 9. 45 mg/dl vs. The expected result of 6. 61 mg/dl. Biased results of the direction and magnitude observed may lead to inappropriate physician action if the issue were to occur undetected on patient samples. The higher than expected vitros ca results were obtained when processing a qc fluid. There was no indication from the customer that vitros ca patient results were questioned by clinicians. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00169 |
| MDR Report Key | 8184352 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-12-04 |
| Device Manufacturer Date | 2017-11-17 |
| Date Added to Maude | 2018-12-20 |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CA SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | CJY |
| Date Received | 2018-12-20 |
| Catalog Number | 1450261 |
| Lot Number | 0305-0560-5594 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2018-12-20 |