MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-06 for VITROS CHEMISTRY PRODUCTS CA SLIDES 1450261 manufactured by Ortho-clinical Diagnostics.
[130622859]
The investigation determined that lower than expected vitros calcium (ca) quality control (qc) results were attained using vitros chemistry products ca slides and vitros chemistry products performance verifiers in combination with a vitros 350 chemistry system. A definitive assignable cause could not be determined. However, based on the information available, a potential cause of this event is a non-reactive cartridge where the integrity of the foil wrapper is compromised during shipment or storage on site, exposing the slides to ambient conditions. However, this could not be verified. The lower than expected vitros ca results were isolated to two slide cartridges from the same box of vitros ca slides. Acceptable vitros ca results were obtained from the cartridges in use prior to the affected cartridges and using an alternate slide cartridge (same lot) after the affected slide cartridges were unloaded from the instrument. A review of historical vitros ca quality control data indicated acceptable qc performance apart from results obtained from the two suspect vitros ca cartridges. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros ca slide lot 0313-0571-9275. Within-run precision testing used to assess the performance of the vitros 350 chemistry system was performed and acceptable results were attained. Therefore, an instrument issue was ruled out as a contributor to this event.
Patient Sequence No: 1, Text Type: N, H10
[130622860]
A customer reported lower than expected vitros calcium (ca) quality control (qc) results obtained using vitros chemistry products ca slides and vitros chemistry products performance verifiers in combination with a vitros 350 chemistry system. Vitros performance verifier ii lot x5905 results of 8. 66, 8. 49 and 8. 56 mg/dl versus the expected result of 12. 1 mg/dl. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. There was no allegation of patient harm as a result of this event. This report is number 1 of 3 mdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00148 |
| MDR Report Key | 8139244 |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2018-12-06 |
| 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 CA SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | CJY |
| Date Received | 2018-12-06 |
| Catalog Number | 1450261 |
| Lot Number | 0313-0571-9275 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2018-12-06 |