MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-21 for DIMENSION? XPAND PLUS WITH HM manufactured by Siemens Healthcare Diagnostics Inc.
[3468830]
Discordant falsely elevated hemoglobin a1c (hb1c) patient results were obtained on three patients on a dimension xpand plus with hm system. The results were reported to the physician(s) who did not question the elevated results. After obtaining an acceptable calibration with lot ga4028, the customer re-tested the patient samples and the corrected results were reported. There are no known reports of patient intervention or adverse health consequences due to the discordant high hemoglobin a1c (hb1c) patient results.
Patient Sequence No: 1, Text Type: D, B5
[10862324]
Siemens was contacted by the customer who requested assistance with calibrating hemoglobin a1c (hb1c). The customer received arithmetic errors on the raw calibration data for lot ga4112. The customer calculated the data and accepted a bad calibration, therefore the tsc determined that the cause of the discordant hb1c results was user error. The falsely elevated hb1c results were caused by testing samples with a bad calibration. The issue was resolved when the customer re-calibrated using an alternate flex lot. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00280 |
| MDR Report Key | 3183160 |
| Report Source | 05,06 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-05-29 |
| Date of Event | 2013-05-29 |
| Date Mfgr Received | 2013-05-29 |
| Device Manufacturer Date | 2010-03-04 |
| Date Added to Maude | 2013-09-13 |
| 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 | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? XPAND PLUS WITH HM |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-06-21 |
| Model Number | DIMENSION? XPAND PLUS WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-21 |