MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-07 for DCA 2000+ manufactured by Siemens Healthcare Diagnostics.
[21988217]
Customer has reported 3 examples of albumin/creatinine ratio (acr) results which have not correlated with the pts acr trend. No injury was reported with the event.
Patient Sequence No: 1, Text Type: D, B5
[22201776]
Customer reported 3 examples of albumin/creatinine ratio (acr) results which have not correlated with the pts acr trend. The customer sent the samples for confirmation testing to another laboratory to confirm the results were incorrect. The(b)(4) who oversee this customer are concerned that the albumin results did not flag appropriately at >300 mg/l. (pt 3 did report correctly) however, sample 2 should have, given the package insert indicates up to 2000 mg/l. Mfr is investigating.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00064 |
| MDR Report Key | 2913603 |
| Report Source | 07 |
| Date Received | 2013-01-07 |
| Date of Report | 2012-11-08 |
| Date of Event | 2012-11-08 |
| Date Mfgr Received | 2012-11-08 |
| Date Added to Maude | 2013-02-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCA 2000+ |
| Generic Name | DCA 2000+ |
| Product Code | JIR |
| Date Received | 2013-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-01-07 |