MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-09-27 for CHOL2 CHOLESTEROL GEN.2 05168538190 manufactured by Roche Diagnostics.
[55722540]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55722541]
The customer received questionable chol2 cholesterol gen. 2 results for an unknown number of patient samples from cobas c701 serial number (b)(4). The customer had performed qc which was in range, so they began testing patient samples. Two hours later, the customer noticed high results (about 2 g/l higher) compared to the patient samples performed in the morning. The customer repeated qc which was high, replaced the reagent pack, recalibrated, and performed qc which was acceptable. The samples that had high results were repeated with the new reagent pack. Data was provided for five patient samples as examples. Patient 1: initial result 4. 19 g/l, repeat result 2. 27 g/l. Patient 2: initial result 3. 69 g/l, repeat result 1. 73 g/l. Patient 3: initial result 4. 19 g/l, repeat result 2. 22 g/l. Patient 4: initial result 3. 84 g/l, repeat result 1. 85 g/l. Patient 5: initial result 4. 92 g/l, repeat result 2. 31 g/l. Information concerning if any erroneous results was reported outside the laboratory was requested, but it was not unknown. The patients were not adversely affected. At the end of the day, the customer repeated qc on the suspect reagent pack and the results were lower than those received earlier in the day. It was noted when the high results were discovered, half of the reagent pack had been consumed. The suspected reagent was inspected and it was found that the color was different between compartment b and c. Compartment c had a darker color than compartment b. It was suspected that oxidation of compartment c had occurred.
Patient Sequence No: 1, Text Type: D, B5
[63494551]
The cholesterol reagent cassette has the same reagent in both compartments b and c. Tests are first pipetted out of compartment b (around 1500 tests) and then the instrument starts pipetting out of compartment c. The investigation suspected that while opening the cassette, something contaminated compartment c leading to an oxidation of the reagent as only the reagent in compartment c was affected. A blank calibration and qc done with compartment b was acceptable comparable to the previous calibrations. When the instrument switched to compartment c, the qc and patient samples recovered too high due to the oxidation. The following full calibration was then probably pipetted out of compartment c and the high standard 1 absorbance was seen. As no other reagent cassettes of this lot showed this behavior, it was assumed this was a single incidence and did not occur during production. No other similar complaints with this or any other lot of the reagent have been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01472 |
| MDR Report Key | 5979855 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-27 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-09-15 |
| Date Added to Maude | 2016-09-27 |
| 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 | CHOL2 CHOLESTEROL GEN.2 |
| Generic Name | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2016-09-27 |
| Model Number | NA |
| Catalog Number | 05168538190 |
| Lot Number | 145482 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-27 |