MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-10 for IMMULITE 1000 BR-MA LKBR manufactured by Siemens Healthcare Diagnostics Products, Limited.
[6837024]
Discordant, falsely elevated cancer antigen 15-3 (ca 15-3) results were obtained on three patient samples on an immulite 1000 instrument using lot 302. The discordant results for samples 34 and 1128 were not reported to the physician(s), while the discordant result for patient 3 was reported to the physician(s). Sample 1128 was repeated on the immulite instrument, resulting higher than the initial result. All three samples were tested on an alternate platform, resulting lower. The repeat results for samples 34 and 1128 from an alternate platform were reported to the physician(s). It is unknown if the repeat results for patient 3 was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca 15-3 results.
Patient Sequence No: 1, Text Type: D, B5
[14213801]
A siemens headquarters support center (hsc) specialist reviewed the quality control (qc) adjustment data and indicated that the adjustment showed a high coefficient of variance (cv) with the low adjustor. The cvs were out of the manufacturing ranges. The cause of the discordant, falsely elevated ca 15-3 results on three patient samples was related to the high cvs.
Patient Sequence No: 1, Text Type: N, H10
[31830982]
The initial mdr 2432235-2015-00324 was filed on july 10, 2015. The first supplemental mdr 2432235-2015-00324_s1 was filed on july 24, 2015. Additional information (10/28/2015): after multiple attempts, no further information could be obtained from the customer. The cause of the discordant, falsely elevated ca 15-3 results on three patient samples was consistent with a site specific reagent issue.
Patient Sequence No: 1, Text Type: N, H10
[40000013]
Corrected information (06/14/2015): the initial mdr was filed with a date of 06/15/2015. The correct date is 06/14/2015. This has been corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00324 |
| MDR Report Key | 4906915 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-10 |
| Date of Report | 2015-06-14 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | REG # 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 1000 BR-MA |
| Generic Name | IMMULITE 1000 BR-MA |
| Product Code | MOI |
| Date Received | 2015-07-10 |
| Model Number | IMMULITE 1000 |
| Catalog Number | LKBR |
| Lot Number | 302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | REG # 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Brand Name | IMMULITE 1000 BR-MA |
| Generic Name | IMMULITE 1000 BR-MA |
| Product Code | MOI |
| Date Received | 2015-07-10 |
| Model Number | IMMULITE 1000 |
| Catalog Number | LKBR |
| Lot Number | 302 |
| 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 | REG # 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-10 |