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 2019-03-22 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[139704182]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139704183]
The initial reporter complained of discrepant high results for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module. The customer was comparing results between the naf sample tube and the results from the lithium-heparin sample tube. The initial result from the naf tube 1162 mg/dl with a data flag. The sample was repeated and the result was 1715 mg/dl. The initial result from the lithium-heparin tube was 173 mg/dl. The result of 1715 mg/dl was reported outside of the laboratory. The naf tube was repeated with a result of 1061 mg/dl with a data flag. The sample was repeated with a result of 1645 mg/dl. On (b)(6) 2019 the lithium-heparin tube was repeated with a result of 141 mg/dl. The naf tube was repeated again with a result of 1134 mg/dl with a data flag. The sample was repeated with a result of 1663 mg/dl. On (b)(6) 2019 the lithium-heparin tube was repeated again with a result of 100 mg/dl. The naf tube was repeated again with a result of 1074 mg/dl with a data flag. The sample was repeated with a result of 1618 mg/dl with a data flag. There was no allegation that an adverse event occurred. The c501 module serial number was (b)(4). The customer was not having issues with other assays, calibration and qc were acceptable and instrument maintenance was up to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01177 |
| MDR Report Key | 8443309 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-22 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-03-22 |
| 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 | 2019-03-22 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | 371182 |
| 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 | 2019-03-22 |