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 2016-11-15 for CHOLESTEROL REAGENT, CONCENTRATED (CHOL_C) manufactured by Siemens Healthcare Diagnostics Inc..
[59900448]
The customer contacted a siemens customer care center (ccc) specialist. The customer had reviewed the instrument log and stated that the reagent volume was low. On (b)(6) 2016, the customer installed a new reagent kit on the instrument and on (b)(6) 2016, the reagent bottle showed a high amount of sedimentation. A siemens technical application specialist (tas) homogenized the reagent bottle and an hour post homogenization, the reagent bottle showed sedimentation again. The cause of the discordant chol_c results on patient samples is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[59900449]
The customer obtained discordant results for concentrated cholesterol (chol_c) on two patient samples on an advia 1800 instrument, while using reagent kit 377159. The samples were repeated on the same instrument and the results were lower. The initial results were reported to the physician(s), and questioned. The corrected results were reported to the physician(s). While reviewing the event log, the customer discovered that there were discordant chol_c results on other patient samples. It is unknown if those samples were repeated. It is unknown if the initial or repeat results were reported to the physician(s) for the additional patient samples. There are no reports of patient intervention or adverse health consequences due to the discordant chol_c results.
Patient Sequence No: 1, Text Type: D, B5
[63816289]
The initial mdr 2432235-2016-00697 was filed on november 15, 2016. Additional information ((b)(6) 2016): a siemens headquarters support center (hsc) specialist reviewed the data provided by the customer. The hsc specialist determined that there was settling of the reagent, which is a known issue that occurs when the reagent is not maintained at 2-8 celsius. The sediment is due to the surfactants used in the reagent. The hsc specialist recommended that the customer should maintain the temperature and resume the testing once the cloudiness has disappeared. The customer followed the recommendations and obtained acceptable results upon repeat testing. The hsc specialist determined that the cause of the discordant chol_c results on patient samples was due to improper storage of the reagent, which led to precipitation of the surfactants in the reagent wedge. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00697 |
| MDR Report Key | 6101533 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-15 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2016-11-18 |
| Date Added to Maude | 2016-11-15 |
| 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 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | REGISTRATION # 8020890 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTEROL REAGENT, CONCENTRATED (CHOL_C) |
| Generic Name | CHOLESTEROL REAGENT, CONCENTRATED (CHOL_C) |
| Product Code | CHH |
| Date Received | 2016-11-15 |
| Model Number | CHOLESTEROL REAGENT, CONCENTRATED (CHOL_C) |
| Lot Number | 377159 |
| 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 INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |