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 APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte. Ltd..
[4128639]
A customer reported that the instrument applied biosystem 7500 fast dx (cat. No. 4407205), with serial number (b)(4) had inconsistent % cv compared to the % cv obtained from two other 7500 fast dx instruments. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[11512868]
Device intended use: the applied biosystems 7500 fast dx real-time pcr instrument with the (b)(4) 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. The instrument was repaired by replacing the lamp. This is the initial and final report for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2013-00031 |
| MDR Report Key | 3624260 |
| Report Source | 04,07 |
| Date Received | 2013-12-09 |
| Date of Report | 2012-09-07 |
| Date of Event | 2012-09-01 |
| Date Mfgr Received | 2012-09-07 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2014-04-01 |
| 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. GRAND ISLAND |
| Manufacturer City | NEW YORK 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 739256 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 739256 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Generic Name | NSU 862.2570 |
| Product Code | NSU |
| Date Received | 2013-12-09 |
| Catalog Number | 4407205 |
| Lot Number | 275030451 |
| 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 | 2013-12-09 |