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 2017-03-31 for ELECSYS VITAMIN B12 IMMUNOASSAY 07212771190 manufactured by Roche Diagnostics.
[71577499]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71577500]
The customer received questionable low elecsys vitamin b12 immunoassay results for patient samples and quality control material with reagent lot 20727101. The customer was questioning results dating back to (b)(6) 2017. The customer received new reagent lot 20727103 on (b)(6) 2017 and repeated patient samples that had been previously tested with reagent lot 20727101. Of the data provided, only the results for two patient samples were discrepant. Patient 1: the initial result was 171. 6 pg/ml and was reported outside the laboratory. The sample was repeated with reagent lot 20727103 with a result of 339. 1 pg/ml. Patient 2: the initial result was 83. 3 pg/ml and the repeat result was 95. 88 pg/ml. The repeat result with reagent lot 20727103 was 206. 6 pg/ml. This patient was a female born in 1930. The low results were reported outside the laboratory and were questioned by the physician. There was no allegation of an adverse event. The reported results were corrected. The customer used cobas e 411 immunoassay analyzer serial number (b)(4). The quality control recovery also increased with reagent lot 20727103. Review of the calibration data provided showed all signals were well within the expected range. The customer is no longer using reagent lot 20727101 and has had no further issues since using reagent lot 20727103.
Patient Sequence No: 1, Text Type: D, B5
[74188627]
A specific root cause could not be determined. An unknown problem during transportation of the suspect reagent pack in combination with an unknown handling issue by the customer was the most probable root cause. Based on the qc data provided, a general reagent issue was not suspected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00687 |
| MDR Report Key | 6449918 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-31 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-03-31 |
| 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 | 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 | ELECSYS VITAMIN B12 IMMUNOASSAY |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2017-03-31 |
| Model Number | NA |
| Catalog Number | 07212771190 |
| Lot Number | 20727101 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-31 |