MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-11-07 for MULTISTIX 10-SG 100 USA 10336425 manufactured by Siemens Healthcare Diagnostics.
[59353281]
The customer states she has prescribed antibiotics to patients with elevated results and has ordered further testing. The customer has received replacement strips and is fully operational on the new strips.
Patient Sequence No: 1, Text Type: N, H10
[59353282]
The customer reported that some leukocyte results were incorrectly reported out due to deteriorated strips and patients were prescribed antibiotics that were not necessary. Specific data was not provided on these samples.
Patient Sequence No: 1, Text Type: D, B5
[63925760]
The reagent was returned for investigation. The investigation of the desiccants demonstrated that the strips were exposed to excessive moisture. Visual appearance of strips also consistent with moisture exposure. Per the multistix ifu: "protection against exposure to light, heat, and ambient moisture is mandatory to guard against altered reagent reactivity". "discoloration or darkening of the test pads may indicate deterioration. " the customer is operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002637618-2016-00138 |
| MDR Report Key | 6082693 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-11-07 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2016-11-21 |
| Date Added to Maude | 2016-11-07 |
| 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 | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBALL ELECTRONICS |
| Manufacturer Street | UL. POZENANSKA 1/C POLAND SP.Z O.O |
| Manufacturer City | TARNOWO PODGORNE, 62080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISTIX 10-SG 100 USA |
| Generic Name | MULTISTIX 10 SG |
| Product Code | JIR |
| Date Received | 2016-11-07 |
| Catalog Number | 10336425 |
| Lot Number | 512065 |
| Device Expiration Date | 2017-06-30 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-07 |