MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-07 for BUN FLEX REAGENT CARTRIDGES K1021 * manufactured by Siemens Medical Solutions Diagnostics Sub.
[18373625]
Bun testing on siemens vista analyzer gave sporadically falsely increased values. This was detected by nephrologist after receiving numerous unexplained elevated values on his patients. Re-ran all testing for previous 24 hours and 58 patient results needed to be corrected due to incorrect initial values. Lab staff contacted the rep, who said that a recall had been issued two days before, but the notice had not reached our facility. The notice was not sent by overnight mail or called. It was sent via regular mail. The manufacturer was notified the day we discovered the erroneous readings. On that date, the manufacturer notified us that a recall had been issued on this reagent two days earlier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1412004 |
| MDR Report Key | 1412004 |
| Date Received | 2009-07-07 |
| Date of Report | 2009-07-07 |
| Date of Event | 2009-06-14 |
| Report Date | 2009-07-07 |
| Date Reported to FDA | 2009-07-07 |
| Date Added to Maude | 2009-07-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUN FLEX REAGENT CARTRIDGES |
| Generic Name | REAGENT |
| Product Code | CDS |
| Date Received | 2009-07-07 |
| Model Number | K1021 |
| Catalog Number | * |
| Lot Number | 09061AA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS SUB |
| Manufacturer Address | SIEMENS MEDICAL SOLUTIONS USA, 511 BENEDICT AVENUE TARRYTOWN NY 10591509 US 10591 5097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-07 |