MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-06-29 for BLOCK CYCLER 96 S 05047927001 manufactured by Roche Molecular Systems.
[2825981]
A customer site in (b)(6) alleged that a large amount of invalid results were generated after changing a thermal cycler on the cobas x 480 instrument (the amplification and detection instrument used with the cobas 4800 system). Specifically, the customer has noticed an increase of more than 10 invalid results post the replacement of a tc block material # 05015162001, sn (b)(4). The cobas x 480 has completed all the runs in question with no hardware error or warning. It is unknown if erroneous results were generated.
Patient Sequence No: 1, Text Type: D, B5
[9814005]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[10274341]
Date of follow-up information was received. Follow up report 1. Additional information / device evaluation. Device evaluated by manufacturer yes. A customer site in (b)(4) alleged that a large amount of invalid results were generated after changing a thermal cycler on the cobas x 480 instrument. An initial investigation into this issue determined that the tc block contained a control sensor that was out of specification. The root cause for the out of specification control sensor is still being investigated; the outcome of the investigation will be communicated through another follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19059860]
(b)(4) - root cause was invesitgated and could not be determined. Investigation into this issue determined that the thermal cycler block contained a control sensor that was out of specification. Upon investigation there was no trend found in the field. The control sensor resistance specification is checked during instrument production and the likelihood of an offset in the resistance is rare. The root cause for the out of specification control sensor was not determined. The manufacturer (measurement specialties) was contacted to conduct destructive testing of the blockcycler. However, further analysis was unable to be performed as it would cause damage and the results would be inconclusive. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00029 |
| MDR Report Key | 2635750 |
| Report Source | 01,05 |
| Date Received | 2012-06-29 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-03-15 |
| Date Mfgr Received | 2012-11-05 |
| Date Added to Maude | 2012-10-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOCK CYCLER 96 S |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2012-06-29 |
| Catalog Number | 05047927001 |
| Lot Number | 028704 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-29 |