MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-06-19 for DIMENSION? CLINICAL CHEMISTRY SYSTEM DF19 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[4429282]
Siemens healthcare diagnostics inc. Was informed on (b)(4) 2014 of an incident with a patient hospitalized in (b)(6) 2006. The complaint alleges that the ammonia flex(r) reagent cartridge (amon, df19) results obtained on a patient on the siemens dimension rxl max instrument were not correct. It is alleged that the low amon results on the siemens instrument contributed to inappropriate treatment decisions. The patient died (b)(6) 2006.
Patient Sequence No: 1, Text Type: D, B5
[12111403]
Siemens healthcare diagnostics inc. Was informed on (b)(4) 2014 of an incident with a patient hospitalized in (b)(6) 2006. Examination of siemens complaint records for the 2006 period does not indicate any complaints filed by the dokkyo account on amon in 2006. Siemens has inquired but has not been provided with information necessary to evaluate the complaint including: -lot number of amon reagent in use at time of testing. -age of the patient. -details on other testing (blood or other diagnostic procedures) performed concurrently. -specimen handling, age, and storage prior to testing. Insufficient information has been provided to help determine if the results obtained could have contributed to the patient death. We have no information to suggest that qc testing was not within acceptable laboratory ranges in the time period of the testing or that there were any recorded reagent or instrument malfunctions. Per reference: tietz textbook of clinical chemistry, 2nd edition; c. A. Burtis, e. R. Ashwood; p. 642. Citrullinemia is known to promote excess ammonia levels in blood. Siemens is continuing to investigate the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00063 |
| MDR Report Key | 3884635 |
| Report Source | 01,05,06 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-05-22 |
| Date of Event | 2006-06-10 |
| Date Mfgr Received | 2014-05-22 |
| Date Added to Maude | 2014-06-19 |
| 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 | 0 |
| Health Professional | 0 |
| 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 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | AMMONIA FLEX? REAGENT CARTRIDGE |
| Product Code | JIF |
| Date Received | 2014-06-19 |
| Catalog Number | DF19 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-06-19 |