MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for VITROS CHEMISTRY PRODUCTS BUBC SLIDES 8383051 manufactured by Ortho-clinical Diagnostics.
[139090110]
The investigation determined that lower than expected vitros bu results from a neonatal patient sample were attained using vitros chemistry products bubc slides in combination with a vitros 250 chemistry system. A definitive assignable cause could not be determined. Based on quality control data, there is no indication that a vitros bubc reagent issue contributed to the event. Furthermore, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros bubc slides lot 0232-0414-0058. A transient reagent issue related to a specific cartridge or series of cartridges cannot be ruled out as a contributing factor as multiple lower than expected results were reported consecutively. Pre-service within run precision testing did not meet expectations. A field engineer went to the site and performed multiple service actions including incubator cleaning and several adjustments. After service actions were completed, the customer reported the instrument had been returned to expected operation. An instrument issue cannot be ruled out as a contributing factor to the event.
Patient Sequence No: 1, Text Type: N, H10
[139090111]
A customer reported lower than expected vitros bu results obtained from a neonatal patient sample processed using vitros chemistry products bubc slides in combination with a vitros 250 chemistry system. Vitros bu results of <1. 2 and <1. 2 mg/dl versus an expected result of 14. 3 mg/dl. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The lower than expected bu results were not reported from the laboratory. There were no allegations of patient harm as a result of this event. This report is number 2 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 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 | 1319809-2019-00006 |
| MDR Report Key | 8339063 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2018-05-21 |
| Date Added to Maude | 2019-02-14 |
| 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 BUBC SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | CIG |
| Date Received | 2019-02-14 |
| Catalog Number | 8383051 |
| Lot Number | 0232-0414-0058 |
| Device Expiration Date | 2019-11-01 |
| 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 | 2019-02-14 |