MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-06 for HOMOCYSTINE ENZYMATIC ASSAY 05385415190 manufactured by Roche Diagnostics.
[5568183]
The customer reported receiving lower control values for homocysteine enzymatic assay (hcys) on reagent lot number 69781101 when comparing to a different reagent lot number 60430301. Controls were in range for reagent lot number 60430301. The customer also had concerns about what appears to be patient results for lot 69781101 when comparing to lot 60430301. Refer to the attached data for the patient results. It is not known when these results were obtained. It is not known if the same samples were used for repeat testing. A clarification has been requested. It is not known if any erroneous results were reported outside of the laboratory. A clarification has been requested. It was asked, but it is not known if any patients were adversely affected. No adverse events were alleged. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12835917]
Additional information received on (b)(6) 2015 indicates date received by manufacturer, should be (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
[12877185]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[33269321]
Date of event, should be (b)(6) 2015. The customer indicated that each set of patient results were from the same sample. Erroneous results were reported outside of the laboratory but it is not known which results. It is not known what patients were affected. It is not known if any patients were adversely affected as the customer does not know which results were erroneous. Investigation results determined that the under recovery of edta plasma samples is related to an aging effect of reagent lot 697811 when the lot neared the end of its shelf life. The reagent lot of 697811 had achieved 12 months shelf life. This issue affects edta plasma samples only. Serum is not affected. This issue is related to one bulk of reagent of 697811 and only occurs for reagent that has aged >12 months. The key enzyme of the test hmtase (homocysteine s-methyltransferase) is strongly mg++ dependent. As the reagent neared the end of its shelf life, the sample bias became evident with edta samples where mg++ in the reagent was more easily chelated from the enzymes. A field corrective action will be initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00915 |
| MDR Report Key | 4491614 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-03-20 |
| Date of Event | 2015-01-12 |
| Date Mfgr Received | 2015-01-12 |
| Date Added to Maude | 2015-02-06 |
| 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 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 | HOMOCYSTINE ENZYMATIC ASSAY |
| Generic Name | HOMOCYSTEINE TEST |
| Product Code | LPS |
| Date Received | 2015-02-06 |
| Model Number | NA |
| Catalog Number | 05385415190 |
| Lot Number | 69781101 |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |