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 2018-02-26 for IMMULITE 2000 CMV IGM L2KCM2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[101310393]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse made alignments on the photomultiplier tube (pmt) shutter and reagent probe. The cse checked the tube lifter, wash station, shaker bars and reagent dual resolution dilutor (drd) and did not find any issue. 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 2432235-2018-00082 and mdr 2432235-2018-00083 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[101310394]
Discordant, (b)(6) results were obtained for a patient sample on an immulite 2000 xpi instrument. The sample was repeated on the immulite 2000 xpi cmv igm assay and the repeat results were also (b)(6). The immulite 2000 xpi cmv igm results were not reported to physician(s). The same sample was tested on an alternate platform and resulted (b)(6) which was reported to physician(s). There are no known reports of patient intervention due to the (b)(6) results. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the (b)(6) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00084 |
| MDR Report Key | 7298021 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-26 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-26 |
| Date Added to Maude | 2018-02-26 |
| 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 | 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 | 2018-02-26 |
| Model Number | IMMULITE 2000 CMV IGM |
| Catalog Number | L2KCM2 |
| Lot Number | 283 |
| Device Expiration Date | 2018-08-31 |
| 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 | 2018-02-26 |