MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-15 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[136256346]
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Patient Sequence No: 1, Text Type: N, H10
[136256347]
The customer complained of a questionable gluc3 glucose hk gen. 3 result for 1 lipemic patient sample tested on a cobas 6000 c (501) module. The initial gluc3 result was 449 mg/dl. The patient sample was tested on another cobas c501 analyzer with gluc3 result of 326 mg/dl. The patient sample was ultracentrifuged and tested on the original analyzer with a gluc3 result of 221 mg/dl. The customer also mentioned that the patient sample was tested on an istat instrument and using glucose strips with results between 220 - 230 mg/dl. No erroneous results were reported outside of the laboratory. The gluc3 result of 221 mg/dl was deemed to be correct. There was no adverse event. The cobas c501 serial number was (b)(4). The customer did not request service as they believed the issue was sample specific. The patient sample was noted to be milky and cloudy and was clearer after being ultracentrifuged. The initial centrifuge time of the patient sample was not within the sample tube manufacturers recommendations. Ultracentrifugation is also not an approved method in product labeling. On the day of the event, there were multiple abnormal probe sucking alarms. The patient sample was not available for further investigation and therefore a pre-analytical issue could not be verified. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00625 |
| MDR Report Key | 8343129 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-15 |
| 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 | 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 | GLUC3 GLUCOSE HK GEN.3 |
| Generic Name | HEXOKINASE, GLUCOSE |
| Product Code | CFR |
| Date Received | 2019-02-15 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-02-15 |