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 2013-03-08 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM KC460 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3174998]
Biased low digoxin results were obtained on qc samples upon calibration with a new lot of calibrator. It is unknown if patient results were reported to the physician. It is unknown if patient treatment was altered or prescribed as a result of the biased low digoxin results. There was no report of adverse health consequences as a result of the biased low digoxin results.
Patient Sequence No: 1, Text Type: D, B5
[10520106]
Siemens healthcare diagnostics inc. Has confirmed customer complaints of low qc and patient recovery for digoxin when this calibrator lot is used to calibrate the digxn method. Internal testing has confirmed an average 15% low bias in the therapeutic range of 0. 9 to 2. 0 ng/ml. The cause of the bias low in digoxin recoveries is calibrator inaccuracy. Siemens healthcare diagnostics inc. Conducted a voluntary recall for dimension vista drug 4 cal (kc460) lot 2kd052 and drug 4 cal (kc460a) lot 2kd053. An urgent medical device recall, communication #13-13, was issued in february 2013 to impacted customers. Customers were instructed to immediately discontinue use and to discard any remaining inventory of dimension vista drug 4 cal (kc460) lot 2kd052 and drug 4 cal (kc460a) lot 2kd053.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2013-00059 |
| MDR Report Key | 2994370 |
| Report Source | 01,05,06 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-14 |
| Date of Event | 2013-02-03 |
| Date Mfgr Received | 2013-02-14 |
| Device Manufacturer Date | 2012-11-09 |
| Date Added to Maude | 2013-05-14 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2517506-03-06-2013-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | DRUG 4 CALIBRATOR |
| Product Code | DLJ |
| Date Received | 2013-03-08 |
| Catalog Number | KC460 |
| Lot Number | 2KD052 |
| Device Expiration Date | 2014-05-01 |
| 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 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-08 |