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 2013-06-05 for DIMENSION(R) CLINICAL CHEMISTRY SYSTEM RD701 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[18858994]
A customer complains of qc shifts with troponin i (ctni) with lot rd23241 of dimension(r) chemistry wash. It is unknown if patient results were reported to the physicians while qc was out of lab range. It is unknown if patient treatment was altered or prescribed while qc results were out of range. There was no report of adverse health consequences as a result of the shifts in ctni results.
Patient Sequence No: 1, Text Type: D, B5
[19290168]
Siemens healthcare diagnostics has confirmed complaints of dimension(r) chemistry wash causing qc and patient sample result shifts. Internal investigation has confirmed shifts can be encountered in two scenarios: when an affected lot of chemistry wash is placed on the instrument following an unaffected lot, a negative bias will be seen on ctni, ltni, tsh, pbnp and lpbn. A positive bias will be seen on ft4. If any of these assays are calibrated using an affected lot of chemistry wash, qc should return within range; but when a subsequent unaffected chemistry wash lot is placed into use, a positive bias will be seen on ctni, ltni, tsh, pbnp and lpbn. A negative bias will be seen on ft4. Siemens healthcare diagnostics inc. Issued an urgent medical device correction letter, (b)(4), in may 2013. The letter stated that siemens has confirmed that changing the chemistry wash lot can cause qc and patient sample result shifts. The letter directed customers to discontinue use and discard remaining inventory of the following lots of chemistry wash: rd23031, rd23111, rd23241, rd23311, rd23391, and rd23461. The letter advised customers to ensure ctni, ltni, tsh, ft4, pbnp and/or lpbn assays have been calibrated using an unaffected lot of chemistry wash.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2013-00233 |
| MDR Report Key | 3146809 |
| Report Source | 01,05,06 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-05-07 |
| Device Manufacturer Date | 2012-11-19 |
| Date Added to Maude | 2013-08-23 |
| 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 | 2517506-05-17-2013-006-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION(R) CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY WASH |
| Product Code | JMG |
| Date Received | 2013-06-05 |
| Catalog Number | RD701 |
| Lot Number | RD23241 |
| Device Expiration Date | 2013-05-19 |
| 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 | 2013-06-05 |