MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-04-21 for VERITI DX THERMAL CYCLER 4452300 manufactured by Life Technologies Holdings Pte. Ltd..
[4659058]
A customer reported a problem of an exceeded maximum hold undershoot coming from veriti dx thermal cycler (cat no. 4452300, serial no. (b)(4)). This causes the instrument to stop in the middle of a run. No pt involvement reported. The company event tracking no. Is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12064633]
Device is an instrument and is not implanted/explanted. The instrument was returned to life technologies corp and repaired by replacing power amplifier & damper. After repair, the instrument passed all the calibration, final tests, performance specifications. The instrument was sent back to the customer. The device was used as a diagnostic. Device intended use can be found on page 3 other remarks. 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 lab techniques and procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00008 |
| MDR Report Key | 3855695 |
| Report Source | 04,07 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-03-04 |
| Date Mfgr Received | 2014-03-04 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-06-23 |
| 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 RD |
| Manufacturer City | GRAND ISLAND NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Manufacturer G1 | LIFE TECHNOLOGIES HOLDINGS PTE. LTD |
| 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 | THERMOCYCLER, GENERIC |
| Product Code | OUL |
| Date Received | 2014-04-21 |
| Catalog Number | 4452300 |
| Lot Number | 299120264 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| Manufacturer Address | SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-21 |