MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for DIMENSION VISTA? SYSTEM K7024 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[24133129]
Siemens healthcare diagnostics has confirmed an increase in the rate of "abnormal assay" errors and calibration failures with the dimension vista(r) b2mic flex(r) reagent cartridge lot 15037ma. The errors can occur on calibration, qc and/or patient samples. As stated in the dimension vista operator's guide, results with abnormal assay flags are not reportable. Siemens healthcare diagnostics issued an urgent medical device recall communication, 15-51, dated july 2015 instructing customers to discontinue use of b2mic lot 15037ma as a result of the issue. Customers were instructed to discard any remaining inventory of the lot and to contact siemens healthcare diagnostics for replacement product. Note due to problem with fda submission website; codes caused rejection of esubmission gateway: codes which would have been used are: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24133130]
The customer reported a high frequency of flagged abnormal assay results on qc and patient samples with the beta-2 microglobulin (b2mic) flex (r) reagent cartridge on the dimension vista instrument. Results with abnormal assay errors were not reported to physicians. There is no indication that patient treatment was altered or prescribed on the basis of the high frequency of flagged abnormal assay flags with the b2mic reagent. There is no indication of adverse patient impact due to the high frequency of flagged abnormal assay flags with the b2mic reagent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2015-00027 |
| MDR Report Key | 4998325 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-04-27 |
| Date Mfgr Received | 2015-07-14 |
| Device Manufacturer Date | 2015-02-06 |
| Date Added to Maude | 2015-08-12 |
| 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 | 3 |
| Event Location | 3 |
| 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 PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-07232015-005-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION VISTA? SYSTEM |
| Generic Name | B2MIC FLEX? REAGENT CARTRIDGE AND URINE STABILIZER |
| Product Code | JZG |
| Date Received | 2015-08-12 |
| Catalog Number | K7024 |
| Device Expiration Date | 2016-07-14 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |