MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-12 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K3085 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[2976713]
A falsely elevated iron result was obtained on qc and two patient samples. The patient results were reported to the physician. A repeat of the same samples was performed on the same instrument (new reagent compartment within the same flex(r) cartridge) and lower results were obtained for both patient samples. It is unknown if patient treatment was altered or prescribed. There was no report of adverse health consequences as a result of the falsely elevated iron results.
Patient Sequence No: 1, Text Type: D, B5
[10196248]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated iron results is unknown. The false elevation was corrected by switching to a new reagent compartment within the same flex(r) cartridge. The issue is under investigation by siemens healthcare diagnostics. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[15295563]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated iron results is reagent cartridge well contamination. Dimension vista iron is composed of two reagents in different wells. Elevated results occur for 15 results, which represents a well set composed of a well of each reagent. Siemens has determined that the elevated results are due to environmental contamination of a reagent well, which results in the elevation of results by the same magnitude for the group. When a well is contaminated with trace amounts of iron, the entire well set is impacted to the same magnitude. An urgent medical device correction dated (b)(4) 2012 was issued to all dimension vista iron customers; to notify them of the issue, the potential risk to health, and actions to be taken by customers. Workaround instructions were provided to customer to first disable the normal flow of iron testing; to batch the processing of iron test in groups of 15 on the instrument, and to run qc on each well set to determine if the well set is contaminated. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2012-00228 |
| MDR Report Key | 2740544 |
| Report Source | 05,06 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-23 |
| Date Mfgr Received | 2012-08-24 |
| Device Manufacturer Date | 2012-05-09 |
| Date Added to Maude | 2012-12-26 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-10-08-2012-015-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | IRON FLEX? REAGENT CARTRIDGE |
| Product Code | JIY |
| Date Received | 2012-09-12 |
| Catalog Number | K3085 |
| Lot Number | 12130BB |
| Device Expiration Date | 2013-05-09 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-09-12 |