MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-21 for FRT REAGENT D129211 manufactured by Siemens Healthcare Diagnostics.
[3106627]
The customer ran patient samples with expired ferritin reagent. The quality controls were within range and the patient results were believable to the customer. It is unknown if patient results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to use of the expired ferritin reagent.
Patient Sequence No: 1, Text Type: D, B5
[10388855]
The cause of patient samples being run with expired ferritin reagent is user error. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00455 |
| MDR Report Key | 2884154 |
| Report Source | 05,06 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-07-01 |
| Date Mfgr Received | 2012-12-03 |
| Date Added to Maude | 2013-03-25 |
| 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 | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRT REAGENT |
| Generic Name | FRT REAGENT |
| Product Code | DBF |
| Date Received | 2012-12-21 |
| Catalog Number | D129211 |
| Lot Number | 219826 |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-21 |