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 2019-05-30 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[146524202]
Calibration and qc were acceptable.
Patient Sequence No: 1, Text Type: N, H10
[146524203]
The initial reporter complained of discrepant results for 1 patient tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module between the sample from a lithium-heparin tube compared to the sample from an edta tube from the same draw. The initial result from the lithium-heparin tube was 27 mg/dl. The instrument auto-repeated the sample with a result of 25 mg/dl. The sample was repeated twice with results of 23 mg/dl with a data flag and 22 mg/dl with a data flag. The result of 27 mg/dl was reported outside of the laboratory where it was questioned by the physician. The edta tube that was drawn at the same time was run and the result was 91 mg/dl. The repeat result was 89 mg/dl. The results from the edta tube were believed to be correct. No adverse event occurred. The c501 module was (b)(4). The customer thinks the issue is related to this patient sample as they are not experiencing the issue with any other patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-02014 |
| MDR Report Key | 8654314 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-30 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-05-09 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-30 |
| 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 | 2019-05-30 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | 38172101 |
| 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 | 2019-05-30 |