MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[125791160]
The investigation determined that a lower than expected vitros valp result was obtained from a patient sample processed as part of a valp lot to lot correlation using a vitros 5600 integrated system. The most likely assignable cause is a combination of vitros valp lot to lot variability and pre-analytical sample handling. The customer indicated the specimens were tested days beyond original collection date, poured off multiple times, and subjected to multiple refrigeration/ambient temperature cycles. Therefore, it is concluded that the pre-analytical sample handling is a contributor to this event. There was no indication of a performance issue with the vitros valp lots (2511-25-6393 and 2511-26-6711) used in the patient correlation based on qc performance; however, the vitros valp lot 2511-25-6393 accuracy was lower than valp lot 2511-26-6711 as shown with the patient correlation results. The vitros valp lot 2511-26-6711 performance was set to the reference method and therefore, the results from that lot were considered the expected results for this correlation data set. It was confirmed by ortho that both vitros valp lots have performed within ortho release guidelines. There was no indication of a vitros 5600 system malfunction based on acceptable within run precision results.
Patient Sequence No: 1, Text Type: N, H10
[125791161]
The investigation determined that lower than expected valproic acid results were obtained from patient samples using a vitros 5600 integrated system in combination with vitros valp reagent. Sample 1 = 56. 3 versus expected 71. 0 ug/ml; sample 3 = 78. 5 versus expected 98. 6 ug/ml ; sample 8 = 46. 0 versus expected 58. 5 ug/ml; sample 9 = 47. 5 versus expected 59. 9 ug/ml ; sample 15 = 50. 9 versus expected 64. 7 ug/ml; sample 23 = 40. 5 versus expected 52. 3 ug/ml ; sample 24 = 61. 8 versus expected 79. 9, 77. 7 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The patient sample results in question were obtained as part of valp lot to lot correlation study and therefore, no patient results were reported outside the laboratory. There was no allegation of patient harm. This report is number 1 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00039 |
| MDR Report Key | 7958039 |
| Date Received | 2018-10-11 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2017-10-05 |
| Date Added to Maude | 2018-10-11 |
| 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 VALP REAGENT |
| Generic Name | IN VITROS DIAGNOSTICS |
| Product Code | LEG |
| Date Received | 2018-10-11 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-6393 |
| Device Expiration Date | 2019-04-04 |
| 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 | 2018-10-11 |