MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-01-11 for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte Ltd..
[35623005]
On (b)(4) 2015 a field service engineer visited the customer site to address the customer complaint of wavy data being reported from the instrument. The field service engineer inspected the instrument and replaced the existing lamp cable with a thicker cable. After the lamp cable was replaced, the engineer ran performance checks on the instrument. The instrument passed performance check specifications and the customer signed an acknowledgement of the service and repair.
Patient Sequence No: 1, Text Type: N, H10
[35623006]
On (b)(6) 2015, a customer submitted a complaint regarding a 7500 fast dx instrument reporting "wavy data. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[38100971]
An internal investigation of the complaint found that the issue of "wavy data" caused the affected assay run to fail background calibration. This would cause the run to be completed with no results reported. A historical review of the instrument was conducted. The instrument was installed on june 25, 2012. The replacement of the lamp cable on (b)(6) 2015 was the first instance the lamp cable was replaced. The cause of the replacement was attributed to normal wear and tear of the part. No further investigation is being conducted on the instrument.
Patient Sequence No: 1, Text Type: N, H10
[38100972]
On (b)(6) 2015, a customer submitted a complaint regarding a 7500 fast dx instrument reporting "wavy data. " internal reference# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003673482-2016-00001 |
| MDR Report Key | 5359368 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-01-11 |
| Date of Report | 2015-12-14 |
| Date of Event | 2015-12-14 |
| Date Mfgr Received | 2015-12-14 |
| Date Added to Maude | 2016-01-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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. |
| Manufacturer Street | BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, NO. 07-06 |
| Manufacturer City | SINGAPORE NORTH WEST, SINGAPORE 739256 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 739256 |
| 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 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Product Code | NSU |
| Date Received | 2016-01-11 |
| Catalog Number | 4407205 |
| 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 | BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, NO. 07-06 SINGAPORE NORTH WEST, SINGAPORE 739256 SN 739256 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-11 |