MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-06 for ORTHO VERSEIA PIPETTER 5561701 manufactured by Ortho Clinical Diagnostics.
[20855991]
During an ocd internal review on (b)(4) 2014 for (b)(4) it was discovered that plate bk0856 from testing date (b)(4) 2013 to the hbsag assay had a control well that did not pipette. (b)(4). Upon discovery, cts contacted the customer on (b)(4) 2014 to determine if the plate was dispositioned (b)(4). Customer investigated and determined that plate bk0856 from (b)(4) 2013 was aborted per (b)(4) and all sample testing was repeated.
Patient Sequence No: 1, Text Type: D, B5
[21156715]
On (b)(4) 2013, ortho clinical diagnostics (ocd) notified customers ((b)(4)) of an ortho verseia? Pipetter software issue that can occur during plate processing when the verseia? Pipetter performs the? Retry? Function to recover from a? No tip? Error (hamilton error code 8). The letter stated that the previously generated results may have been impacted. Ocd customer technical services will review all available data received via e-connectivity to identify any adverse events and will inform customers of any erroneous results generated due to this issue. Any devices not e-connected, ocd will be working with customers to obtain historical data from these instrument(s). The letter also listed the following required actions;? Discard all results for any plate for which a plate pipette error report lists a? No tip? Error after processing on the ortho verseia? Pipetter. ? Post this notification in your laboratory or with your user documentation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250051-2014-00044 |
| MDR Report Key | 3793448 |
| Report Source | 05 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-05-06 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2014-04-07 |
| Date Added to Maude | 2014-06-24 |
| 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 | MS. MARTA CARNIELLI |
| Manufacturer Street | 1001 ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082181000 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO VERSEIA PIPETTER |
| Generic Name | SAMPLE PIPETTER |
| Product Code | MMH |
| Date Received | 2014-05-06 |
| Model Number | 5561701 |
| Catalog Number | 5561701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 ROUTE 202 RARITAN NJ 08869 US 08869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-06 |