MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[100431285]
The investigation determined that higher and lower than expected vitros vanc results were obtained from vitros control fluids and non-vitros control fluids processed on a vitros 5600 integrated system. The assignable cause of the lower than expected vitros vanc results is a reagent pack related issue. The affected results were isolated to a single reagent pack. The issue with the affected reagent pack is unknown, as the pack was discarded by the customer and no further investigation was possible. The assignable cause of the higher than expected vitros vanc results is improper fluid handling as the control fluids were improperly stored at room temperature. Acceptable quality control results were obtained when using fresh controls. There is no evidence to suggest the vitros 5600 system malfunctioned. With the exception of the affected reagent pack, based on historical quality control results there was no indication that vitros vanc reagent lot 2514-36-6074 was not performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[100431286]
A customer obtained higher and lower than expected vitros vanc results from vitros quality controls and non-vitros quality control fluids using vitros vanc reagent on a vitros 5600 integrated system. Biorad level 1 lot 40951 vitros vanc result 16. 27 ug/ml versus expected vanc result 15. 90 ug/ml. Biorad level 2 control lot 40952 vitros vanc result < 5. 0 and <5. 0 ug/ml versus expected vanc result 15. 90 ug/ml. Vitros tdm pvi lot v6155 vitros vanc result 19. 30 ug/ml versus the midpoint of the vitros tdm pvi range of means 7. 50 ug/ml. Vitros tdm pvii lot t5896 vitros vanc result <5. 0 ug/ml versus the midpoint of the vitros tdm pvii range of means 39. 8 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 higher and lower than expected vitros vanc results were obtained when processing quality control fluids on the vitros 5600 system. Ortho was not made aware of any allegation of patient harm as a result of this event. However the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. This report is number two of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00009 |
| MDR Report Key | 7266662 |
| Date Received | 2018-02-13 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-01-16 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-02-13 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 VANC REAGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LEH |
| Date Received | 2018-02-13 |
| Catalog Number | 6801709 |
| Lot Number | 2514-36-6074 |
| ID Number | 10758750006731 |
| Device Expiration Date | 2018-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-02-13 |