MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[128434455]
The investigation determined that lower than expected valproic acid (valp) results were obtained from patient samples processed as part of a valp lot to lot correlation using a vitros 4600 chemistry system. The most likely assignable causes for this event are valp lot to lot variability and calibration to calibration variability. There was no indication of a performance issue with the vitros valp lots (2511-25-6067, 2511-26-6711 and 2511-26-6892) used in the patient correlation based on quality control (qc) performance; however, the vitros valp lot 2511-25-6067 accuracy was lower than both valp lots 2511-26-6711 and 2511-26-6892 as shown with the patient correlation results. Valp gen 26 performance was set to the reference method at release and resulted in a shift high over gen 25 performance. It was confirmed by ortho that both vitros valp gen 25 and gen 26 lots have performed within ortho release guidelines. The performance of vitros controls were acceptable and ortho release data was within specifications. Furthermore, the customer indicated that any shift in patient data seen was not considered to be clinically significant at the time. Additionally, because pre-analytical specimen storage and handling information were not provided, pre-analytical sample handling and storage cannot be ruled out as a contributing factor to this event.
Patient Sequence No: 1, Text Type: N, H10
[128434456]
A customer obtained lower than expected valproic acid (valp) results from patient samples using a vitros 4600 chemistry system in combination with vitros valp reagent. Sample 1 = 35. 7 versus expected 52. 3 mg/l. Sample 2 = 23. 4 versus expected 34. 5 mg/l. Sample 3 = 79. 5 versus expected 104. 8 mg/l. Sample 4 = 91 versus expected 118 mg/l. Sample 6 = 102. 8 versus expected 128. 7 mg/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. Ortho has not been 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 numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00045 |
| MDR Report Key | 8048155 |
| Date Received | 2018-11-07 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2017-05-05 |
| Date Added to Maude | 2018-11-07 |
| 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 DIAGNOSTICS |
| Product Code | LEG |
| Date Received | 2018-11-07 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-6067 |
| Device Expiration Date | 2018-11-05 |
| 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 | 2018-11-07 |