MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-10 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[52876249]
The investigation determined that a lower than expected vitros dgxn quality control result was obtained on a vitros 5600 integrated system. The investigation could not determine the most likely assignable cause for the event. Historical dgxn quality control results obtained from the mas controls indicated within-lab imprecision was occurring, therefore a dgxn slide lot issue cannot be ruled out as contributing to the event. An issue with the mas control fluids in use cannot be ruled out as contributing to the event. Acceptable within-lab precision was obtained using a vitros control fluid. Finally, an instrument related issue cannot be ruled out. Service actions were performed on the vitros 5600 system, however, no appropriate pre or post within-run precision testing was performed to assess the performance of the vitros system, therefore, it is unknown if the vitros 5600 system was performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[52876252]
A customer observed lower than expected vitros dgxn quality control results obtained on a vitros 5600 integrated system. Quality control result of 0. 4 ng/ml versus an expected result of 1. 86 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegation that patient sample results were affected, however, the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected. There was no allegation of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00079 |
| MDR Report Key | 5866659 |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-07-13 |
| Date Mfgr Received | 2016-07-13 |
| Device Manufacturer Date | 2016-04-06 |
| Date Added to Maude | 2016-08-10 |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2016-08-10 |
| Catalog Number | 8343386 |
| Lot Number | 1909-0236-1229 |
| Device Expiration Date | 2016-09-01 |
| 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 | 2016-08-10 |