MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for IMMULITE / IMMULITE 1000 AFP LKAP manufactured by Siemens Healthcare Diagnostics Products, Limited.
[68137447]
The customer contacted a siemens customer care center and stated that they checked their quality controls and adjustments, which were acceptable. A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer and stated that as per immulite 1000 afp instructions for use, "values obtained with different afp assays cannot be used interchangeably. Before changing assays, the laboratory must confirm baseline values for patients being serially monitored". The hsc specialist stated that if the patient is baselined on one platform, they need to stay on that platform. Since this was the first time this patient was run on the immulite 1000 instrument, the patient would need to be baselined. The hsc specialist reviewed quality controls for all assays and other patient samples evaluated for afp, which were acceptable. The customer sent two samples to be processed on the alternate platform and then compared the results to those obtained on the immulite 1000 instrument, which were reproducible. The cause of the discordant, falsely low afp results on one patient sample is unknown. The device is performing within manufacturing specifications. No further evaluation of device is needed.
Patient Sequence No: 1, Text Type: N, H10
[68137448]
The customer obtained discordant, falsely low alfa-fetoprotein (afp) results on one patient sample upon initial and repeat testing on immulite 1000 instrument, when using reagent lot 210. The discordant results were reported to the physician(s), who questioned them. The sample was then sent to an alternate laboratory where it was tested on an alternate platform and the result was higher. The sample was sent to a 2nd alternate laboratory where it was tested on another immulite 1000 instrument, also resulting lower. The sample was then sent to a 3rd alternate laboratory where it was tested on an alternate platform and the result was higher. It is unknown if the corrected results from the alternate platforms were reported to the physician(s). There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely low afp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00134 |
| MDR Report Key | 6344115 |
| Date Received | 2017-02-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-26 |
| Date Added to Maude | 2017-02-20 |
| 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 | 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 | 0 |
| Brand Name | IMMULITE / IMMULITE 1000 AFP |
| Generic Name | IMMULITE / IMMULITE 1000 AFP |
| Product Code | LOK |
| Date Received | 2017-02-20 |
| Model Number | IMMULITE / IMMULITE 1000 AFP |
| Catalog Number | LKAP |
| Lot Number | 210 |
| 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 | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-20 |