MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[82997054]
The investigation has determined that a lower than expected vitros valp result was obtained from a single patient correlation sample processed using vitros chemistry products valp reagent, lot 2511-25-5727 on vitros 5600 integrated system s/n (b)(4). The most likely assignable cause of the event is unknown, however, improper pre analytical sample storage cannot be ruled out as contributing to the event. It is unknown if the affected sample was stored using the protocol stated in the vitros chemistry products valp reagent instructions for use. In addition, a calibration related issue or an instrument related issue cannot be ruled out as contributing to the event. The issue was resolved after performing the routine maintenance actions of replacing the photometer lamp, performing a water blank procedure, and recalibrating vitros chemistry products valp reagent, lot 2511-25-5727.
Patient Sequence No: 1, Text Type: N, H10
[82997055]
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a lower than expected result was obtained from a single patient correlation sample processed using vitros chemistry products valp reagent on a vitros 5600 integrated system. Patient sample 2 result of 24 ug/ml versus an expected result of 34. 0 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. The customer made no indication that erroneous patient sample results were reported from the laboratory. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00013 |
| MDR Report Key | 6790984 |
| Date Received | 2017-08-14 |
| Date of Report | 2019-01-04 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2017-08-14 |
| 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 | 2017-08-14 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-5727 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-04-30 |
| 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 | 2017-08-14 |