MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2011-03-14 for REFLOTRON HEMOGLOBIN 30 10744964203 manufactured by Roche Diagnostics.
[9120738]
One vial of test strips was returned by the customer for investigation. The customer's materials and retention samples were tested and were found to be within specification. All measurements gave results within specified ranges. Internal capillary blood testing revealed the quality of the batches used during testing were within specification. No malfunction was detected. Since the investigation showed the material met specification, it was recommended the customer check sample collection and preparation as outlined in the package insert. No adverse events were reported associated with this issue.
Patient Sequence No: 1, Text Type: N, H10
[17959527]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[17977870]
The customer conducted pulic health care profiles at different locations several different days during a period of several weeks. The health profiles included glucose, cholesterol and hemoglobin testing. The participants were females (b)(6) and males (b)(6). The total number of participants was not provided. The customer provided 39 patient results tested in three different cities using the same hemoglobin strip lot number 20332603. Hemoglobin results from three of the participants were discrepant. Participant 1, male, initial result was <50 g/l. The participant was tested two more times. The first repeat result was >200 g/l. The second repeat result was 165 g/l. Participant 2, initial result was >200 g/l. The repeat results were >200 and 157 g/l. The date of testing was not provided. Participant 3, initial result was was >200 g/l. The repeat results were >200 g/l and 176 g/l. The date of testing was not provided. The participants were recommended to visit there ordinary health care provider for further investigation. No adverse events have been alleged regarding the discrepancies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2011-01378 |
| MDR Report Key | 2018224 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-02-10 |
| Date Mfgr Received | 2011-02-18 |
| Date Added to Maude | 2011-03-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON HEMOGLOBIN 30 |
| Generic Name | WHOLE BLOOD HEMOGLOBIN DETERMINATION |
| Product Code | KHG |
| Date Received | 2011-03-14 |
| Returned To Mfg | 2011-03-02 |
| Model Number | NA |
| Catalog Number | 10744964203 |
| Lot Number | 20332603 |
| ID Number | NA |
| Operator | PHARMACIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN NA US NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-14 |