MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-03 for SYVA? EMIT? 2000 PHENOBARBITAL ASSAY 4D019UL manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3838744]
Imprecise phenobarbital (phno) results were obtained on qc and patient samples run on the toshiba accurate analyzer. It is unknown if patient results were reported to the physician. The account complains of imprecison with the recovery of calibrator bottle values. It is unknown if patient treatment was altered or prescribed on the basis of the imprecision with the phno assay. There was no report of adverse health consequences as a result of the imprecise phno results.
Patient Sequence No: 1, Text Type: D, B5
[10918421]
Siemens healthcare diagnostics has confirmed in internal studies that lot e6 of emit 2000 phenobarbital assay exhibits increased imprecision and outliers on a variety of clinical analyzers. Siemens issued an urgent medical device recall, communication # 13-62 in august, 2013 to recall emit 2000 phenobarbital lots, including e6. Customers were instructed to discontinue use of the affected lots and were offered a no charge replacement of an alternate lot.
Patient Sequence No: 1, Text Type: N, H10
[32640110]
Original mdr was submitted 09-03-2013. Siiemens healthcare diagnostics has identified the root cause of the imprecision and implemented corrective and preventive actions. It has been determined that aggregation of glucose-6-phosphate dehydrogenase (g6pdh) antibody caused the imprecision. Siemens healthcare diagnostics has qualified the removal of the g6pdh antibody from the reagent, validated, and implemented the change.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2013-00360 |
| MDR Report Key | 3323250 |
| Report Source | 05,06 |
| Date Received | 2013-09-03 |
| Date of Report | 2013-08-29 |
| Date of Event | 2013-06-14 |
| Date Mfgr Received | 2013-08-29 |
| Device Manufacturer Date | 2013-04-04 |
| Date Added to Maude | 2013-12-03 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-08-30-2013-008-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYVA? EMIT? 2000 PHENOBARBITAL ASSAY |
| Generic Name | SYVA? EMIT? 2000 PHENOBARBITAL ASSAY |
| Product Code | DLZ |
| Date Received | 2013-09-03 |
| Catalog Number | 4D019UL |
| Lot Number | E6 |
| Device Expiration Date | 2013-10-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-03 |