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 2018-12-19 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[131145748]
Patient Sequence No: 1, Text Type: N, H10
[131145749]
The customer complained of questionable gluc3 glucose hk gen. 3 results for 1 patient tested on a cobas 6000 c (501) module that are not fitting the patient's clinical picture. The customer stated that the questionable results have been obtained from two separate blood draws. The initial blood draw was on (b)(6) 2018 and a second blood draw was done on (b)(6) 2018. The gluc3 results from the (b)(6) 2018 blood draw were not provided, but it was stated by the customer that the results were similar to the gluc3 results from the sample on (b)(6) 2018. The gluc3 results from (b)(6) 2018 were released to the physician and were the reason why a second sample was collected on (b)(6) 2018. On (b)(6) 2018 the initial gluc3 result was 40 mg/dl with a data flag and the repeat result was 36 mg/dl with a data flag. The patient had a fingerstick glucose result of 98 mg/dl and from a sample that was collected in a lavender top tube (k2 edta) a gluc3 result of 102 mg/dl was obtained. It was unknown which glucose result was deemed to be correct. There was no adverse event. The cobas c501 serial number was (b)(4). It was stated that all other basic metabolic panel results for the patient were normal. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04976 |
| MDR Report Key | 8178410 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-12-19 |
| 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 | 2018-12-19 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | 34296901 |
| Device Expiration Date | 2019-09-30 |
| 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 | 2018-12-19 |