MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-02-28 for VITROS CHEMISTRY PRODUCTS LI SLIDES 1632660 manufactured by Ortho-clinical Diagnostics.
[19021172]
A lower than expected vitros li result (qc level ii < 0. 20 versus expected 1. 09 mmol/l) was obtained from a quality control fluid processed on a vitros 250 chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. There was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19128591]
The investigation determined that a lower than expected vitros li result was obtained from a qc fluid run on a vitros 250 chemistry system. The evaluation of historical laboratory results demonstrated that reagent lot in question had good accuracy prior to the date of the event. The investigation determined that the issue was isolated to a specific vitros li slide cartridge that was suspected to be non-reactive. Acceptable vitros li performance was achieved using an alternate slide cartridge without any changes being made to the vitros 250 chemistry system. The assignable cause of the non-reactive slide cartridge could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2014-00011 |
| MDR Report Key | 3653652 |
| Report Source | 00,01,05 |
| Date Received | 2014-02-28 |
| Date of Report | 2014-02-28 |
| Date of Event | 2013-12-25 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2012-08-08 |
| Date Added to Maude | 2014-05-12 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS LI SLIDES |
| Generic Name | IN-VITRO DOAGNOSTIC |
| Product Code | JIH |
| Date Received | 2014-02-28 |
| Catalog Number | 1632660 |
| Lot Number | 3119-0091-1725 |
| Device Expiration Date | 2014-02-01 |
| 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 | 513 TECHNOLOGY BLVD. ROCHESTER NY 14652 US 14652 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-28 |