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 2018-09-12 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[119950639]
Patient Sequence No: 1, Text Type: N, H10
[119950640]
The customer questioned low results for 1 patient tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module. The initial gluc3 result was 29 mg/dl with a data flag. This result was not reported outside of the laboratory as the customer was not sure if it was correct. At 6:42 a. M. The patient had a result from an accu-chek meter of 92 mg/dl. The original sample was repeated on the c501 module and the result was 27 mg/dl with a data flag. This result was reported outside of the laboratory as it was close to the initial result of 29 mg/dl with a data flag. The doctor questioned the result of 27 mg/dl with a data flag. The point of care staff decided to test the patient on the accu-chek meter. At 8:26 a. M. The patient had a result from the meter of 111 mg/dl. The results from the accu-chek meter were believed to be correct. The sample was repeated on a different c501 module for troubleshooting purposes and the result was 26 mg/dl with data flag. The customer repeated the sample one more time on the different c501 module and the result was 26 mg/dl with a data flag. These results were not reported outside of the laboratory. On (b)(6) 2018 a new sample was obtained and the result from the initial c501 module was 107 mg/dl. This result was believed to be correct and was reported outside of the laboratory. The patient is not showing any symptoms of hypoglycemia. The physician stated the patient has a very high white count that could affect the glucose results. The customer was not having any issues with other patients tested for gluc3. No adverse event occurred. The c501 module serial number was (b)(4). The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03076 |
| MDR Report Key | 7867923 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2018-09-12 |
| 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 | 2018-09-12 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | ASKU |
| 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 | 2018-09-12 |