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 2017-08-18 for IMMUNOGLOBULIN M 20737771322 manufactured by Roche Diagnostics.
[86137160]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86137161]
The customer was comparing results from a cobas integra 800 to results from an abbott c4000 for igm immunoglobulin m and igg immunoglobulin igg. The patient samples were originally run on a cobas integra 800 between the dates of (b)(6) 2017-(b)(6) 2017. The same patient samples were then run on a recently installed abbott 4000 as part of a correlation study. Of the data provided for one the one patient sample, only the results for igm were discrepant. The specific date of testing was not provided. The igm result from the cobas integra 800 was 1841 mg/dl. The igm result from the abbott c4000 was 1384 mg/dl. The customer does not know which result is accurate. The cobas integra 800 results were reported outside of the laboratory. There were no adverse events. The serial number for the cobas integra 800 is (b)(4). A field engineering specialist was dispatched to investigate the cobas integra 800. He did not find any problems with the analyzer. He performed precision testing which passed. The customer ran qc which passed. Review of the provided calibration and qc data found both were acceptable. As the result was above the measuring range for the assay, a gammopathy cannot be excluded for this patient. Product labeling for the assay documents this interference.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01762 |
| MDR Report Key | 6804579 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-18 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-08-18 |
| 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 | IMMUNOGLOBULIN M |
| Generic Name | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) |
| Product Code | CFN |
| Date Received | 2017-08-18 |
| Model Number | NA |
| Catalog Number | 20737771322 |
| Lot Number | 18806701 |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| 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 | 2017-08-18 |