MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[114819654]
The investigation has determined that a higher than expected vitros valp result was obtained when processing a patient sample during a patient correlation on a vitros 5600 system. The most likely assignable cause is calibration to calibration variability. The customer processed a lot to lot patient comparison and noted a shift low in valp results generated using the new valp reagent lot. The customer recalibrated vitros valp lot 2511-25-5974 and repeated the patient comparison using the same vitros 5600 system and an alternate vitros 5600 system in the laboratory. The recalibration of vitros valp lot 2511-25-5974 resulted in acceptable quality control and patient correlation results on both vitros 5600 systems. This would indicate that, while acceptable, the calibration performed on 12 january 2018 was different enough from the new calibration to be considered suboptimal. The investigation concluded the assignable cause was calibration to calibration variability. There was no indication that an instrument issue contributed to the event. In addition, a complaint review of valp lot 2511-25-5974 did not indicate a reagent issue. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp lot 2511-25-5974. The mdr is being submitted after the 30 day reporting date due to a technical issue with ortho? S mdr reporting system. Ortho was unable to electronically submit mdrs from 5 july 2018? 19 july 2018.
Patient Sequence No: 1, Text Type: N, H10
[114819655]
A customer obtained a higher than expected vitros valp result from a single patient sample tested on a vitros 5600 system during a patient correlation. Patient 4 sample, vitros valp (2511-25-5974) result 403 umol/l versus the vitros valp (lot 2511-25-6393) results 332 and 331 umol/l. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The higher than expected vitros valp result was not reported from the laboratory. Ortho was not made aware of any erroneous patient sample results that were obtained or reported from the laboratory. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00020 |
| MDR Report Key | 7707136 |
| Date Received | 2018-07-20 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2018-07-20 |
| 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 | 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 VALP REAGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LEG |
| Date Received | 2018-07-20 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-5974 |
| Device Expiration Date | 2018-08-14 |
| 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 | 2018-07-20 |