MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for BD ESR? BI-LEVEL QC MATERIAL (4X8,5ML) 361555 manufactured by Becton Dickinson.
[147069199]
(b)(4). Medical device expiration date: unknown. (b)(6). Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[147069200]
It was reported that there were 2 occurrences with inaccurate results were being reported with bd esr? Bi-level qc material (4x8, 5ml). The following information was provided by the initial reporter: the opened bsg controls give too low values when measured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-00724 |
| MDR Report Key | 8510910 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD ESR? BI-LEVEL QC MATERIAL (4X8,5ML) |
| Generic Name | ESR INSTRUMENT |
| Product Code | GHC |
| Date Received | 2019-04-12 |
| Catalog Number | 361555 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |