MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-04 for MULTISTIX 10 SG 2161 manufactured by Siemens Healthcare Diagnostics Inc.
[19294101]
Customer reported false negative white blood cells (wbc) and false negative nitrite on three patients. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[19394879]
Customer has been requested to send back reagent for further investigation. The cause for the discordant results is unknown. Customer has not had any additional issues since complaint was opened.
Patient Sequence No: 1, Text Type: N, H10
[34945722]
An inspection was completed by technical operations on returned reagent multistix 10 sg lot #401070 & comparison lot #311023 tested by visual method on one (1) qualified reader using test solutions contrived to leukocyte (leu) & nitrite (nit) sensitivity ranges published in reagent product insert [leu: 5 & 10 c/mcl; nit: 0. 06 & 0. 10 mg/dl]. N=12 reps per test level, per lot. 100% positive results for both lots at both nit test levels. 100% positive results for both lots at 10 c/mcl leu test level. Borderline results for both lots at 5 c/mcl leu test level -- 5 of 12 strips for the returned lot showed trace color development, as did 4 of 12 strips for the comparison lot. Customer observation of false negative leu & nit results when visually reading multistix 10sg lot 401070 cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[34945723]
White blood cells/leukocyte.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2014-00076 |
| MDR Report Key | 3847704 |
| Report Source | 05 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-06-26 |
| Date Added to Maude | 2014-07-03 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBELL ELECTRONICS POLAND SP.Z.O.O. |
| Manufacturer Street | UL. POZNANSKA 1/C |
| Manufacturer City | TARANOW PODGOME, 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISTIX 10 SG |
| Generic Name | MULTISTIX 10 SG |
| Product Code | LJX |
| Date Received | 2014-06-04 |
| Catalog Number | 2161 |
| Lot Number | 401070 |
| Device Expiration Date | 2015-07-01 |
| Operator | MEDICAL ASSISTANT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-06-04 |