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 2016-09-12 for IMMULITE 2000 CMV IGM L2KCM manufactured by Siemens Healthcare Diagnostics Products, Limited.
[54507766]
Siemens healthcare diagnostics has confirmed increased imprecision on some patient samples with the immulite? /immulite? 1000 cmv igm reagent lots 330 and 331 and on the immulite? 2000 / immulite? 2000 lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, and 267. These samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across nonreactive, indeterminate, and reactive ratios. Quality controls provided in the cmv igm kit may not detect the imprecision with patient results. An urgent field safety notice (ufsn) imc 16-22a. Ous was sent out to customers and an urgent medical device recall (umdr) imc16-22. A. Us was sent to us customers in august 2016. The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lots listed above. Siemens recommends transitioning to immulite 2000/2000 xpi cmv igm kit lots 268 and above and immulite 1000 kit lot 332 and above.
Patient Sequence No: 1, Text Type: N, H10
[54507767]
The customer has indicated that they are obtaining increased false reactive and indeterminate results for igm antibodies to cytomegalovirus (cmv igm) assay upon initial and repeat testing on an immulite 2000 xpi instrument when using kit lot 263, 264 and 266. Sample ids (b)(6) were repeated on an alternate platform, resulting as non-reactive. For sample id (b)(6), a repeat non-reactive result from the immulite 2000 xpi instrument was reported to the physician(s). For sample id (b)(6), the customer reported the result as indeterminate and requested a new sample. The customer also reported that there was delay in reporting of patient results. There were no reports of patient intervention or adverse health consequences due to the discordant, false reactive and indeterminate or delay in reporting of cmv igm results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00511 |
| MDR Report Key | 5943869 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-12 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-12 |
| 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 | ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-08/31/2016-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 CMV IGM |
| Generic Name | IMMULITE 2000 CMV IGM |
| Product Code | LKQ |
| Date Received | 2016-09-12 |
| Model Number | IMMULITE 2000 CMV IGM |
| Catalog Number | L2KCM |
| Lot Number | 263, 264 AND 266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-09-12 |