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 2019-02-21 for IMMULITE 2000 CMV IGM L2KCM2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[140634050]
A siemens technical applications specialist (tas) visited the customer site. The tas analyzed the assay adjustment (calibration) data from (b)(6) 2018 and (b)(6) 2018 and the data were within specifications. The recoveries of the quality control (qc) materials were also found to be within specifications. A siemens customer care specialist (ccc) stated that the sample is no longer available for investigation. The cause of the discordant, (b)(6) results on the immulite 2000/ immulite 2000 xpi cmv igm assay is unknown. Siemens is investigating the issue. Mdr 2432235-2019-00071 was filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[140634051]
A discordant, (b)(6) cmv igm result was obtained for a patient sample on an immulite 2000 xpi instrument. The initial immulite 2000 xpi cmv igm result was not reported to physician(s). The same sample was tested on an alternate, non siemens platform and resulted (b)(6) for cmv igm, which was reported to physician(s). The same sample was repeated again on the immulite 2000 xpi instrument and resulted (b)(6). The (b)(6) cmv igm result was in alignment with the patient's clinical profile. There are no known reports of patient intervention due to the (b)(6) cmv igm results. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the (b)(6) cmv igm results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2019-00072 |
| MDR Report Key | 8358008 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-21 |
| Date of Report | 2019-03-08 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-02-21 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 CMV IGM |
| Generic Name | IMMULITE 2000 CMV IGM |
| Product Code | LKQ |
| Date Received | 2019-02-21 |
| Model Number | IMMULITE 2000 CMV IGM |
| Catalog Number | L2KCM2 |
| Lot Number | 287 |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |