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 2017-08-04 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[81848145]
This event occurred in (b)(6). (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[81848146]
The customer stated that they received questionable results for a total of 9 samples from 6 different patients tested for the elecsys cmv igg assay (cmv igg) on a cobas 6000 e 601 module (e601). The customer provided data for one patient sample that had an erroneous result for cmv igg and the elecsys cmv igm immunoassay (cmv igm). The erroneous results were reported outside of the laboratory to the medical doctor. The customer stated that the involved patient had an early primary cmv infection. This medwatch will apply to the cmv igg assay. Please refer to the medwatch with (b)(6) for information related to cmv igm. Refer to the attachment for the patient data. The cmv igg results obtained with the e601 analyzer were negative compared to a clearly positive result from the abbott architect method. The recomline blot method was also performed on the sample and this had an unclear cmv igg result. The cmv igm result from the e601 analyzer was negative compared to a positive result with the recomline blot method. No adverse events were alleged to have occurred with the patient. The e601 analyzer serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[117021734]
Results were questioned from a total of 7 patient samples. The customer provided data for the remaining 6 patient samples. Of these, 4 samples had erroneous results that were reported outside of the laboratory to the medical doctor. Refer to the attachment for all patient data. The attachment also contains the complete set of results for the patient that was originally reported (patient/sample 1). For patient/sample 1, the customer complains that the elecsys (b)(6) and (b)(6) assays do not recognize early primary infection in the patient. The patient has (b)(6) primary infection in pregnancy, partially longitudinal. For patient/sample 2 and patient/sample 3, the customer complains of clear evidence of a (b)(6) elecys (b)(6). Both patients are female, with (b)(6) infection, longitudinal. Patient 2 is (b)(6) years old and patient 3 is (b)(6) years old. For patient/sample 4, the customer complains that elecsys (b)(6) reacted too late. This patient is a female of childbearing age, but not pregnant. The patient has a (b)(6) infection. For patient/sample 5, the customer complains that elecsys (b)(6) does not respond yet. The elecsys (b)(6) result is (b)(6) compared to (b)(6) abbott architect result. This patient is a female of childbearing age, but not pregnant. The patient has a (b)(6) infection. No adverse events were alleged to have occurred for the patients. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01589 |
| MDR Report Key | 6766529 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-04 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-08-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2017-08-04 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| 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 | 2017-08-04 |