MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-03-27 for 3500 XL DX GENETIC ANALYZER CS2 4461444 manufactured by Life Technologies Holdings Pte. Ltd..
[19022828]
A customer reported that the 3500xl dx genetic analyzer cs2 (cat no 4461444, serial no (b)(4)) stopped in the middle of an assay run due to the presence air bubbles. No patient involvement reported. The company event tracking number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19132987]
Device is an instrument and is not implanted/explanted. The instrument was investigated on site. The investigation determined the cause of the air bubbles was due to a leaking pump. The pump was replaced and spatial calibration was run after the repair. The instrument passed required spatial calibration specifications. Device intended use: the applied biosystems 3500xl dx genetic analyzer cs2 with 3500 dx series software 2011 (vl) are in vitro diagnostic devices intended for the sequencing (detection and identification) of fluorescently labeled deoxyribonucleic acid (dna) by capillary electrophoresis. The applied biosystems 3500xl 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 | 3003673482-2014-00007 |
| MDR Report Key | 3815366 |
| Report Source | 04,07 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-01-20 |
| Date of Event | 2014-01-20 |
| Date Mfgr Received | 2014-01-20 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-06-16 |
| 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, GRAND ISLAND |
| Manufacturer City | NEW YORK NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3500 XL DX GENETIC ANALYZER CS2 |
| Generic Name | DNA GENETIC ANALYZER |
| Product Code | PCA |
| Date Received | 2014-03-27 |
| Catalog Number | 4461444 |
| 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 | 2014-03-27 |