MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for CHOLESTEROL GEN. 2 05168538190 manufactured by Roche Diagnostics.
[41056142]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41056143]
The customer questioned cholesterol gen. 2 (chol2) for 81 patient samples tested on the same reagent cassette. Of the data provided, the data for 57 patient samples were erroneous. Erroneous results were reported outside of the laboratory. The initial chol2 results were obtained on (b)(6) 2016. Corrected results were sent to the physician on (b)(6) 2016 when the samples were repeated. It was noted that the customer performs quality controls (qc) once a day at night. When qc was run the night after the initial chol2 results were received, qc recovery was 2-3 times what they normally receive. The customer performed a calibration and these results were higher than normal as well. The chol2 patient samples from the previous day were repeated on (b)(6) 2016 identifying the erroneous results. No adverse event occurred. The c702 analyzer serial number was (b)(4). It was noted that there were no issues when the customer switched to a new reagent cassette and other reagent cassettes were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[42636803]
The customer returned the reagent cassette for investigation. Testing was performed on the customer's reagent cassette and a retention cassette from the investigation site. Calibration and quality control results on both cassettes were within specification. A specific root cause could not be identified. A reagent cassette issue can be excluded. Possible root causes may be related to an instrument or pre-analytic issue.
Patient Sequence No: 1, Text Type: N, H10
[43614127]
Further investigation was performed on the instrument. It was determined that the high results were pipetted from the small bottle of the affected reagent cassette. The possible root cause may be related to contamination of the reagent in the small bottle, even though this was not identified in the prior investigation. No further investigation is possible. A specific root cause for how the small bottle became contaminated was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00337 |
| MDR Report Key | 5514416 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-01 |
| Date Mfgr Received | 2016-03-03 |
| Date Added to Maude | 2016-03-21 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTEROL GEN. 2 |
| Generic Name | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2016-03-21 |
| Model Number | NA |
| Catalog Number | 05168538190 |
| Lot Number | 61638601 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-21 |