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 2018-03-19 for IMMULITE 2000 CYTOMEGALOVIRUS IGG L2KCVG2 manufactured by Siemens Healthcare Diagnostics Inc..
[103290001]
A siemens headquarters support center (hsc) specialist reviewed the event data. The sample was not available for in-house testing. The review of internal kit release between kit lots 326, 327 and 328 did not show any samples that were clinically non-concordant. The hsc specialist could not be determine if the cause of the issue was due to sample precision or a potential non-specific interference. The customer reported indeterminate result as a correct result for the sample in question. As per immulite 2000 xpi cmv igg instructions for use, "any result of indeterminate (ratio between 0. 9 and less than 1. 1) should be retested. Samples which still test as indeterminate should be tested by an alternate method, or a second sample should be taken - if possible - within a reasonable period of time (e. G. , one week). The presence of igg antibodies to cmv is an indication of previous exposure to the virus. A single specimen can only be used to determine the serological status of the individual. " the cause of an indeterminate result being reported to the physician(s) was failure to follow instructions. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[103290002]
A discordant, (b)(6) result for igg antibodies to (b)(6) assay was obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 328. The (b)(6) result was not reported to the physician(s). The sample was initially run using kit lots 326 and 327, resulting indeterminate and (b)(6) respectively. The customer reported an indeterminate result from kit lot 326 and considered it to be correct. The (b)(6) result obtained using kit lot 327 was not reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00108 |
| MDR Report Key | 7349099 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-19 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES 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 CYTOMEGALOVIRUS IGG |
| Generic Name | IMMULITE 2000 CYTOMEGALOVIRUS IGG |
| Product Code | LFZ |
| Date Received | 2018-03-19 |
| Model Number | IMMULITE 2000 CYTOMEGALOVIRUS IGG |
| Catalog Number | L2KCVG2 |
| Lot Number | 328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |