MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-03-06 for 3500 XL DX GENETIC ANALYZER CS2 4461444 manufactured by Life Technologies Holdings Pte. Ltd.
[4499252]
A customer reported there was spatial calibration failure in the instrument, 3500 xl dx genetic analyzer cs2 (cat. No. 4461444, serial no. (b)(4)). No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[11745450]
Device is an instrument and is not implanted/explanted. The instrument was investigated on site. It was discovered that the array door was binding, preventing the laser to pass through capillary. The door/spring was disassembled and lubricated. It was then reassembled and installed. Several spatial calibrations were run after the repair and the instrument passed required specifications. Device intended use: the applied biosystems 3500xl dx genetic analyzer cs2 with 3500 dx series software 2011 (vl) are invitro diagnostic devices intended for the sequencing (detection and identification) of fluorescently-labeled deoxyribonucleic acid (dna) by capillary electrophoresis. The applied biosystems 3500xl dx genetic analyzer cs2 with 3500 dx sequencing assays specifying their use and only by technologists trained in laboratory techniques, procedures and use of the analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00004 |
| MDR Report Key | 3831934 |
| Report Source | 04,07 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-07 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-06-19 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3500 XL DX GENETIC ANALYZER CS2 |
| Generic Name | PCA |
| Product Code | PCA |
| Date Received | 2014-03-06 |
| Catalog Number | 4461444 |
| Lot Number | 25800-221 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-03-06 |