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 2016-11-28 for VITAMIN B12 07212771190 manufactured by Roche Diagnostics.
[60945605]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60945606]
The customer complained that the results for one patient tested for elecsys vitamin b12 immunoassay (vitamin b12) were too high. The patient had an initial vitamin b12 result between 3000-3500 (unit of measure not provided). The sample was repeated and the result was "the same. " these results were provided to the patient? S doctor who believes the results are too high based on the patient? S clinical picture. The doctor is wondering if there is an interference in the sample. No adverse event occurred. The instrument type and serial number was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[64026670]
A specific root cause could not be identified. Additional information was requested for investigation but was not provided.
Patient Sequence No: 1, Text Type: N, H10
[69778821]
A new sample or samples were obtained from the patient on either (b)(6) 2017 or (b)(6) 2017 and retested for vitamin b12. Clarification on the correct date was requested but has not been provided. The unit of measure was provided as ng/l. The customer provided results of 3678 ng/l and 4097 ng/l from (b)(6) 2017. An additional result of 3000 ng/l was provided from (b)(6) 2017. It is not clear if these results are from the same sample or from different samples. The result from a 1/2 manual dilution was provided as 1839 ng/l. The date of this test was not provided. The vitamin b12 reagent lot number for the new results is 207271. The expiration date was not provided. The serial number of the instrument was provided as (b)(4). The instrument type was not provided.
Patient Sequence No: 1, Text Type: N, H10
[71607100]
The customer clarified that the new sample was from (b)(6) 2017. The result provided in a previous follow up report of 3000 ng/l was from the sample obtained on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[75107779]
The patient sample was submitted for investigation. During the initial investigation, the customer's vitamin b12 results were reproduced. Further investigation of the sample confirmed the presence of vitamin b12 complex to igg macro b12. This specific interference is addressed in product labeling. Based on the investigation results, a general reagent issue can most likely be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01848 |
| MDR Report Key | 6129036 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-28 |
| Date of Report | 2017-05-15 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-11-28 |
| 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 | VITAMIN B12 |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2016-11-28 |
| Model Number | NA |
| Catalog Number | 07212771190 |
| Lot Number | ASKU |
| 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 | 2016-11-28 |