D
Patient 1
THE CUSTOMER SITE REPORTED THAT DISCREPANT RESULTS WERE GENERATED FOR A "ROTATING CONTROL" (PREVIOUSLY TESTED PATIENT SAMPLE) WITH THE AMPLICHIP(B)(4) TEST. IT IS UNKNOWN IF ERRONEOUS PATIENT RESULTS WERE REPORTED TO PHYSICIANS.
MAUDE MDR 1694314
- MDR report key
- 1694314
- Report number
- 2243471-2010-00027
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-04-12
- Date received
- 2010-05-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 105
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- VINCENT STAGNITTO
- Address
- 1080 US HWY 202S BRANCHBURG NJ 08876 US
- Phone
- 908-908-9082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AMPLICHIP CYP450 TEST | DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS | ROCHE MOLECULAR SYSTEMS | NTI | 04591402190 | M15616 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-05-19 | 0 |
Event Narratives#
D
Patient 1
UPDATE: THE CUSTOMER SITE INDICATED THAT NO PATIENT RESULTS WERE REPORTED FROM TEST RUNS WITH AN INVALID CONTROL (ROCHE CONTROL OR CUSTOMER EXTERNAL CONTROL).
N
Patient 1
NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. CONCLUSION FROM THE INVESTIGATION WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT.
N
Patient 1
CORRECTED / ADDITIONAL DATA: DESCRIBE EVENT OR PROBLEM: UPDATED, BASED ON CUSTOMER FEEDBACK, TO INDICATE THAT NO PATIENT RESULTS WERE REPORTED FROM INVALID TEST RUNS. DEVICE EVALUATED BY MANUFACTURER: UPDATED TO "NO". UPDATED BASED ON INVESTIGATION CONCLUSIONS. THE COMPLAINT KIT WAS NOT TESTED AS IT WAS DETERMINED, BASED ON THE EVALUATION OF THIS ISSUE, THAT THE CUSTOMER HANDLING OF THE EXTERNAL CONTROLS (PREVIOUSLY POSITIVE PATIENT SAMPLES) LEAD TO THE ISSUE OBSERVED. METHOD: EVALUATION OF THE CUSTOMER'S DATA AND THE CUSTOMER'S WORKFLOW. A CUSTOMER SITE IN THE UNITED STATES REPORTED THAT MISCALL RESULTS FOR THE CYP2D6 GENE WERE GENERATED WITH THEIR EXTERNAL CONTROL AND NO CALL RESULTS WERE GENERATED WITH THE AMPLICHIP CYP450 POSITIVE CONTROL. THE CUSTOMER INDICATED THAT THEIR EXTERNAL CONTROLS ARE PREVIOUSLY EXTRACTED AND TESTED PATIENT SAMPLES THAT HAVE BEEN STORED AT -20 DEGREES C SINCE 2007. NO PATIENT RESULTS WERE REPORTED FROM TEST RUNS WITH EITHER AN INVALID AMPLICHIP CYP450 POSITIVE CONTROL OR THE CUSTOMER'S EXTERNAL CONTROL. THE AMPLICHIP CYP450 TEST IS INTENDED TO IDENTIFY A PATIENT'S CYP2D6 AND CYP2C19 GENOTYPE FROM GENOMIC DNA EXTRACTED FROM A WHOLE BLOOD SAMPLE. INFORMATION ABOUT CYP2D6 AND CYP2C19 GENOTYPE MAY BE USED AS AN AID TO CLINICIANS IN DETERMINING THERAPEUTIC STRATEGY AND TREATMENT DOSE FOR THERAPEUTICS THAT ARE METABOLIZED BY THE CYP2D6 OR CYP2C19 GENE PRODUCT. THE INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE CUSTOMER WAS STORING THEIR EXTERNAL CONTROL OFF-LABEL. AS INDICATED WITHIN THE PRODUCT LABELING, EXTRACTED GENOMIC DNA (UNDILUTED AND DILUTED) SHOULD BE STORED AT 2 TO 8 DEGREES C FOR UP TO ONE WEEK OR FROZEN AT -20 DEGREES C FOR UP TO ONE MONTH, WITH NO MORE THAN THREE FREEZE-THAW CYCLES. STORING EXTRACTED DNA IMPROPERLY (I.E., THREE YEARS AT -20 DEGREES C) LEADS TO DEGRADATION AND CONSEQUENTLY POOR AMPLIFICATION OF THE LARGEST DUPLICATION AND DELETION AMPLICONS. THE INVESTIGATION INTO THIS COMPLAINT DID NOT IDENTIFY ANY PRODUCT PERFORMANCE ISSUES WITH THE AMPLICHIP CYP450 TEST OR THE SPECIFIC COMPLAINT BATCHES. BASED ON THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE DISCREPANT EXTERNAL CONTROL RESULTS OBSERVED BY THE CUSTOMER WERE LIKELY DUE TO MISHANDLING OF THE EXTRACTED GENOMIC DNA BY THE CUSTOMER. (B)(4).