MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[54756452]
The investigation determined that a higher than expected vitros crbm result was obtained during a within run vitros crbm precision test using a vitros quality control fluid on a vitros 350 chemistry system. A definitive assignable cause could not be determined for the higher than expected vitros crbm result. Subsequent vitros crbm within-run precision testing was acceptable, indicating the vitros 350 chemistry system was performing as intended. A vitros crbm reagent issue could not be entirely ruled out as a contributor to the event. The vitros 350 system was in the process of being installed at the customer site; therefore historical quality control results were not available to verify vitros crbm lot 3933-0093-2277 performance. In addition, a pre-analytical sample handling cannot be completely ruled out with the information provided by the ortho laboratory specialist, therefore improper pre-analytical sample handling/processing cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[54756453]
An ortho clinical diagnostics laboratory specialist (ls) obtained a higher than expected, non-reproducible vitros crbm result during a within run vitros crbm precision test using a vitros quality control fluid on a vitros 350 chemistry system. Vitros crbm result >20 ug/ml versus expected result of 13. 75 ug/ml. The higher than expected vitros crbm result was obtained from a vitros control fluid during a vitros 350 chemistry system installation, no patient samples were tested. However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00084 |
| MDR Report Key | 5936633 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2016-05-14 |
| Date Added to Maude | 2016-09-08 |
| 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 CRBM SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | KLT |
| Date Received | 2016-09-08 |
| Catalog Number | 8892382 |
| Lot Number | 3933-0093-2277 |
| Device Expiration Date | 2017-01-01 |
| 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 | 2016-09-08 |