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.
[114826696]
The investigation determined that lower than expected vitros valp quality control results were obtained when using vitros valp reagent lot 2511-25-6393 on a vitros 4600 chemistry system. The investigation was unable to determine a definitive assignable cause for this event. Based on quality control performance on an alternate instrument, the reagent is performing as expected. Therefore, the reagent is not likely to be a contributing factor. The instrument performance was not verified with a within run marker performance test. Although there is no indication the instrument malfunctioned, the instrument cannot be completely ruled out as a contributing factor. Additionally, an issue related to the handling of the tdm fluids or a sub-optimal calibration event cannot be ruled out as a contributing factor to the event the assignable cause is unknown. 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 mdr's from 5 july 2018? 19 july 2018.
Patient Sequence No: 1, Text Type: N, H10
[114826697]
A customer observed lower than expected vitros valp quality control results when using vitros tdm controls on a vitros 4600 chemistry system. Reagent lot 2511-25-6393; vitros tdm performance verifier ii (lot n5702) valp result 53. 09 ug/ml versus the expected vitros valp result 68. 9 ug/ml. Vitros tdm performance verifier iii (lot t5896) valp result 91. 27 ug/ml versus the expected vitros valp result 115. 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. The customer did not process patient samples due to the unacceptable valp quality control results. 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 (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00021 |
| MDR Report Key | 7707381 |
| Date Received | 2018-07-20 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Device Manufacturer Date | 2017-10-05 |
| 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 | 2511-25-6393 |
| Device Expiration Date | 2019-04-05 |
| 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 |