MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-02-19 for VERSANT 440 MOLECULAR SYSTEM 091-A001-04 manufactured by Siemens Healthcare Diagnostics.
[1067714]
An operator noted greater than expected use of cleaning solution and less than expected use of a wash a while running the versant hiv-1 rna 3. 0 assay on the versant 440 molecular system. A field service engineer determined that the lines had been switched during routine service of the instrument. Two (b)(6) and one (b)(6) runs were performed using cleaning solution rather than wash buffer for assay with wash steps. Rlus were lower than normal but controls were within acceptable limits for the assays and result were reported. (b)(6) runs were repeated after the wash line error was corrected. Seven (b)(6) samples re-tested showed discrepancies; of the seven, two samples showed clinically significant differences (3 fold change). (b)(6) results did not show any significant discrepancies upon re-testing. The results initially reported for the (b)(6) samples showing a 3 fold discrepancy were 233 and 236 copies per ml. The repeat testing indicated that both were less than 75 copies/ml. Corrected reports were issued for all seven samples. Testing is underway to confirm the performance of the assay under the fault conditions reported.
Patient Sequence No: 1, Text Type: D, B5
[8186781]
On (b)(4), 2009, a field service engineer went to the customer site to confirm fluidics performance on the versant 440 molecular system and found that the wash a line had been reversed with the cleaning solution line. This was traced to an instrument service performed on (b)(4) 2009 when the lines had been replaced. The problem was corrected by the field service engineer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003932969-2009-00002 |
| MDR Report Key | 1326897 |
| Report Source | 07 |
| Date Received | 2009-02-19 |
| Date of Report | 2009-02-17 |
| Date of Event | 2009-02-03 |
| Date Mfgr Received | 2009-02-03 |
| Date Added to Maude | 2010-08-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SONIA STEWART |
| Manufacturer Street | 725 POTTER ST |
| Manufacturer City | BERKELEY CA 94710 |
| Manufacturer Country | US |
| Manufacturer Postal | 94710 |
| Manufacturer Phone | 5109824068 |
| Manufacturer G1 | SPARTON MEDICAL SYSTEMS |
| Manufacturer Street | 22740 LUNN ROAD |
| Manufacturer City | STRONGSVILLE OH 44149 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44149 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSANT 440 MOLECULAR SYSTEM |
| Generic Name | VERSANT 440 MOLECULAR SYSTEM |
| Product Code | NHS |
| Date Received | 2009-02-19 |
| Model Number | 440 MOLECULAR SYST |
| Catalog Number | 091-A001-04 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-19 |