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 2016-12-12 for IMMULITE 2000 CMV IGM L2KCM manufactured by Siemens Healthcare Diagnostics Products, Limited.
[62265502]
The cause of the false non-reactive cmv igm result on the one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[62265503]
The customer obtained a false non-reactive result for cytomegalovirus igm (cmv igm) on one patient sample on an immulite 2000 xpi, when using kit lot 270. The sample was repeated on an alternate platform, which resulted reactive. The discordant result was not reported to the physician(s). The result obtained from the alternate platform was reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the false non-reactive cmv igm result.
Patient Sequence No: 1, Text Type: D, B5
[64046882]
The initial mdr 2432235-2016-00765 was filed on (b)(6) 2016. Additional information ((b)(6) 2016): the customer did not provide the sample for in-house testing. A siemens headquarters support center (hsc) specialist reviewed the patient data. There was no indication of any issue with the assay or instrument. The cause of the false non-reactive cmv igm result on the one patient sample is unknown. The device is performing as intended. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[67546777]
The initial mdr 2432235-2016-00765 was filed on (b)(6) 2016. The first supplemental mdr 2432235-2016-00765_s1 was filed on (b)(6) 2017. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00765 |
| MDR Report Key | 6166153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-12 |
| Date of Report | 2017-01-26 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2016-12-12 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | 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 | 2016-12-12 |
| Model Number | IMMULITE 2000 CMV IGM |
| Catalog Number | L2KCM |
| Lot Number | 270 |
| 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 | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-12 |