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 2019-01-15 for GLUC3 GLUCOSE HK GEN.3 05168791190 manufactured by Roche Diagnostics.
[133198113]
.
Patient Sequence No: 1, Text Type: N, H10
[133198114]
The customer stated that they have sporadically been getting low results for an unspecified number of patient samples tested with gluc3 glucose hk gen. 3 on a cobas 8000 c 702 module. Some samples will have results of 18, 5, or 2. When repeated, these samples have normal results. The customer provided a specific example for one patient sample with an erroneous result. No erroneous results were reported outside of the laboratory. The unit of measure used for gluc3 was not provided. The sample initially resulted with a value of 18, which repeated around 100. No adverse events were alleged to have occurred with the patient. The serial number of the c 702 module is (b)(4). Quality controls were acceptable. The customer declined a service visit. The customer replaced the reagent pack and stated that the issue was resolved. The investigation could not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00201 |
| MDR Report Key | 8249418 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-15 |
| 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 | 2019-01-15 |
| Model Number | NA |
| Catalog Number | 05168791190 |
| Lot Number | 342842 |
| 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 | 2019-01-15 |