MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-28 for AMPLICOR CT/NG TEST 20759392018 manufactured by Roche Molecular Systems, Inc..
[640489]
In june 2006, roche molecular systems, inc. Provided a product bulletin clarifying the use of the gold plated heat block and the aluminum heat block on the applied biosystems geneamp pcr system 9700 thermal cycler. In response to the the bulletin, the customer reported they had been using the aluminum heat block when performing the amplicor ct/ng test. The aluminum heat block will not accept a maximum ramp speed which is required to perform the amplicor ct/ng test. The current amplicor ct/ng test package insert describes the setting of the temperature ramp speed to maximum but does not identify the heat block to be used.
Patient Sequence No: 1, Text Type: D, B5
[7904144]
The package insert that accompanies the amplicor ct/ng test states in the instructions for use section, part d amplification, step 3 "during run set-up, set the reaction volume to 100ul by first changing the ramp speed from the 9600 mode to the max mode. To do this, cursor down to ramp speed and select max". Applied biosystems geneamp pcr system 9700 thermal cyclers with the aluminum heat block will not accept this setting. Only thermal cyclers equipped with the gold-plated heat block will accept the ramp speed setting of max. The purpose of providing the product bulletin was to provide additional information on this setting requirement. Add'l lot # g14950.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2006-00011 |
| MDR Report Key | 873321 |
| Report Source | 05,07 |
| Date Received | 2006-09-28 |
| Date of Report | 2006-09-13 |
| Date Mfgr Received | 2006-09-15 |
| Date Added to Maude | 2007-07-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 1080 US HIGHWAY 202 |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Street | 1080 US HIGHWAY 202 |
| Manufacturer City | SOMERSVILLE NJ 08876377 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICOR CT/NG TEST |
| Generic Name | IN VITRO DIAGNOSTIC NUCLEIC ACID TEST |
| Product Code | MKZ |
| Date Received | 2006-09-28 |
| Model Number | NA |
| Catalog Number | 20759392018 |
| Lot Number | H02039 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 853691 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | * BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-28 |