MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12 6801697 manufactured by Ortho-clinical Diagnostics.
[105766504]
The investigation has determined that lower than expected vitros valp results were obtained from non-vitros biorad control fluids and vitros tdm performance verifiers (tdm pv) processed using vitros chemistry products valp reagent lot 2511-25-6393 on a vitros 5600 integrated system s/n (b)(4). The most likely assignable cause is a suboptimal calibration due to an issue with vitros calibrator kit 12, lot 1266, as the customer obtained acceptable performance when using vitros valp lot 2511-25-6393 after calibration with an alternative lot of calibrator kit 12. There is no indication that a valp reagent or instrument issue contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[105766505]
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report lower than expected results obtained from non-vitros biorad control fluids and vitros tdm performance verifiers (tdm pv) processed using vitros chemistry products valp slides on a vitros 5600 integrated system. Biorad l1 lot 31841 vitros valp results 18. 87, 17. 66, 17. 93, and 16. 64 ug/ml versus baseline; mean 28. 91 ug/ml. Biorad l2 lot 31842 vitros valp results 96. 34, 99. 44, 98. 20, 94. 15, 93. 56, 109. 6 ug/ml versus; baseline mean 137. 2 ug/ml. Vitros tdm performance verifier iii lot x6157 vitros valp result 83. 6 ug/ml versus the midpoint of the rom 113. 6 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. 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. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4)/qerts record id (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00013 |
| MDR Report Key | 7420521 |
| Date Received | 2018-04-11 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2016-12-07 |
| Date Added to Maude | 2018-04-11 |
| 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 12 |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DLJ |
| Date Received | 2018-04-11 |
| Catalog Number | 6801697 |
| Lot Number | 1266 |
| ID Number | 10758750006618 |
| Device Expiration Date | 2018-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-04-11 |