MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-06-27 for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte Ltd.
[4822769]
A (b)(6) field svc engineer reported that contamination from the heated cover of applied biosystems 7500 fast dx real-time pcr instrument (catalog no. 4407205 serial no. (b)(4)) caused incorrect results to be reported from a run. We were not made aware of any impact to pt management. The company event tracking no: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11943802]
Device is an instrument and is not implanted/explanted. The field svc engineer attributed the contamination issue to wear and tear of the heated cover. The heated cover was replaced and the contamination issue was resolved. Device intended use: the applied biosystems 7500 fast dx real-time pcr instrument with the sds software version 1. 4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed rna and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 fast dx real-time pcr instrument is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00018 |
| MDR Report Key | 3978888 |
| Report Source | 04,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2013-03-07 |
| Date of Event | 2013-03-07 |
| Date Mfgr Received | 2013-03-07 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2014-08-14 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Generic Name | INSTRUMENTATION FOR CLINICAL MULTIP |
| Product Code | NSU |
| Date Received | 2014-06-27 |
| Catalog Number | 4407205 |
| 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 | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |