MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-12-09 for VERITI DX THERMAL CYCLER 4452300 manufactured by Life Technologies Holdings Pte. Ltd..
[16685769]
A customer reported that the instrument veriti dx thermal cycler (catalogue no. 4452300) with serial no. (b)(4) was having a 'error - set point failure' message. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[16711974]
Device intended use: the applied biosystems veriti dx thermal cycler amplifies human nucleic acid samples for diagnostic applications. The veriti dx thermal cycler is to be used only by operators trained in laboratory techniques and procedures. Based on investigation conducted, the instrument gives an error once it reached 95 degrees c. It was tested with working controller pca and it worked. The repair was completed by replacing the controller pca. This is the initial and final report for this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2013-00008 |
| MDR Report Key | 3623818 |
| Report Source | 04,07 |
| Date Received | 2013-12-09 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-05-20 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2014-03-31 |
| 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 | KELLI TANZELLA |
| Manufacturer Street | 3175 STALEY ROAD |
| Manufacturer City | GRAND ISLAND NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Manufacturer G1 | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| Manufacturer Street | BLK 33, MARSILING INDUSTRIAL STATE ROAD 3, #07-06 |
| Manufacturer City | SINGAPORE |
| Manufacturer Country | SN |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERITI DX THERMAL CYCLER |
| Generic Name | OUL 862.2170 |
| Product Code | NSU |
| Date Received | 2013-12-09 |
| Catalog Number | 4452300 |
| Lot Number | 299120182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| Manufacturer Address | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-09 |